PROJECT REPORT

ON
QUALITY CONTROLLED ROLE OF BIOCHEMIST
IN PHARMACEUTICAL CHEMESTRY

Dissertation submitted to the Bahra University in partial

fulfilment of the requirements for degree of
MASTER IN SCIENCES
BIOCHEMISTRY
By
RUCHIKA

(Reg. No.BU2017PGBIO017)
Under the Supervision of
Dr. APRAJITA

SCHOOL OF PHARMACEUTICALS SCIENCES

BAHRA UNIVRESITY, WAKNAGHAT, SHIMLA HILLS, H.P.
June-2019

1
CERTIFICATE

2
 ACKNOWLEDGEMENT

I would like to express my gratitude to IBN Herbal (P) Ltd. Baddi for giving me the opportunity to
undertake my Industrial Training program in the company which gave me an insight into the working of
the oragnization as a whole.

I am very grateful to Mr. Anil Kumar , HR manager, IBN Herbal (P) Ltd.. for giving me an opportunity to
undertake my Industrial Training program at IBN Herbal.

I owe my sincere thanks and heartfelt gratitude to Mr. Anil Kumar , HR manager who has been
instrumental in the successful completion of this project. I am thankful for his guidance and constant
supervision for providing necessary information regarding the successful completion of the project. I
would like to express my gratitude towards employees of IBN Herbal (P) Ltd. for their kind co-operation
and encouragement. Their contribution gave me valuable insights into this project and immense
knowledge of the area.

I emphatically express my thanks to Gurvinder. S. Bahra (Chancellor, Bahra university), Dr.

S.K.Bansal (Vice Chancellor) ,Dr. A. Banerjee. (Dean, School of Pharmaceutical science.) and
to our program manager Dr. Aprajita Bhardwaj for permitting me to do my research work at
ICAR- CPRI(Central Potato Research Institute) ,Shimla.

Under the leadership and guidance of “Mr. Sumit Singla (Proprietor)” we have been able to
achieve the goal of our firm in a well-defined manner. His constant levels of focus and promise
helps us to attain a huge client base.

My deep sense of thanks to Mr. Vitin Dhaka and Paramjeet Kaur for their support in
laboratory.

My deepest gratitude goes to my parents and family for their love and moral support throughout
my life and being a constant source of inspiration to ,build up my education career.

I request indulgence from many friendly & helpful people whom I could not name here, due to
paucity of space. Needless to say, all omissions and errors are mine.

3
 ABSTRACT:
A simple, economical, specific, accurate, precise and validated Reverse phase high
performance liquid chromatography (RP-HPLC) method has been developed for
simultaneous estimation of Phenylepherine hydrochloride (PPEH) and Cetirizine
hydrochloride (CETH) in combine dosage form. The chromatographic separation
was achieved on Princeton SPHER C18 column (250 mm x 4.6 mm id, 5 μ particle
size) at ambient temperature using mobile phase buffer (0.1 M Ammonium
dihydrogen phosphate pH 5.2 ± 0.05) : Acetonitrile (50:50% v/v) at flow rate 1.0
ml/min. Quantification was achieved with UV detector at 225 nm. Retention time
of Phenylepherine hydrochloride and Cetirizine hydrochloride were found to be
2.19 ± 0.05 minute and 4.16 ± 0.05 minute respectively. Linearity was studied in
the concentration range 5-30 μg/ml and 10-60 μg/ml for Cetirizine hydrochloride
and Phenylepherine hydrochloride respectively with a correlation coefficient of
0.9998 and 0.9998 respectively. The proposed method was validated according to
ICH guidelines with respect to linearity, accuracy, precision, robustness, LOD, and
LOQ. The developed method with good separation, successfully applied for
determination of PPEH and CETH in its pharmaceutical dosage form

4
 CONTENT

Chapter TITLE PAGE NO.

1 INTRODUCTION

2 REVIEW OF
LITRARTURE

3 MATERIAL AND
METHODS

4 CALCULATIONS AND
RESULTS

5 CONCLUTION

6 REFRENCES

5
 CHAPTER - 1
INTRODUCTION

INTRODUCTION Quality control is a process that is carried out to ensure a desired level of
quality in a product or service. It might include whatever actions a business deems necessary to
provide for the control and verification of certain characteristics of a product or service. Most
often, it involves thoroughly examining and testing the quality of products or the results of
services. ISO 8402- 1986 standard defines that quality is the totality of features and
characteristics of a product or service that bears its ability to satisfy stated or implicated needs 1 .
Pharmaceutically, we can say quality is checking and directing the degree and grade of
experience of process and products 2 . This process is carried out to validate the product quality,
to produce medication of superior efficacy, safety, and to provide assurance to physician,
pharmacists and patients as well that given product performs satisfactorily and uniformly. When
a number of different formulations are available for the same drug, it becomes essential to ensure
the equivalency (relationship followed by bioavailability, therapeutic response, or a set of
established standards of one drug product to another 3 ) of the products pharmaceutically.
Cetirizine is a long acting antihistamine and unlike conventional or first generation
antihistamines it causes less sedation and psychomotor impairment and as well causes no
behavioral changes. It is a major metabolite of hydroxyzine, and a racemic selective H1 receptor
antagonist used in the treatment of allergies, hay fever, angioedema, and urticaria. The basic goal
of our study was to ensure that the products (cetirizine tablets) that are saturated in Bangladeshi
drug market meet specific requirements and characteristics,

Established in the year 1971, in Solan, (Himachal Pradesh, India), we “IBN

Herbals” are a Sole Proprietor firm, actively engaged in manufacturing and
supplying an extensive range of Antibiotics Tablets, Pharmaceutical Capsules,
Nutraceutical products, Beta Lactam Antibiotic Products, Antiallergic Drugs,
Cephalosporin Category Products and General Products. The herbal medicines

6
provided by us are processed by utilizing supreme quality natural ingredients and
sophisticated machines under the meticulous surveillance of our dexterous
professionals in accordance with set medical standards. These herbal medicines are
highly admired among our prestigious clients owing to their salient features such
as long shelf life, accurate composition, non allergic, free from impurities, highly
effective, precisely processed,  etc. Additionally, we provide these herbal
medicines in variegated packaging options as per the requirements of our valuable
clients with no hassle. Clients can easily purchase these herbal medicines from us
at rock bottom prices with no hassle.

To process the best quality herbal medicines, we possess innovative and advanced
infrastructural facility. We have further integrated our infrastructure facility into
numerous departments such as processing department, quality control department,
logistic department, administration department, research & development
department, transportation department and warehousing & packaging department.
These departments are well-resourced with ultra-modern techniques, machines and
tools that are lubricated and serviced at regular interval in order to enhance the
production capacity. All these departments are supervised by our team of
hardworking and adroit professionals in order to accomplish the voluminous
requirements and necessities of our prestigious customers. With the relentless
efforts and dedication of our team members, we have been able to achieve a
renowned and dynamic position among our customers. 

Under the leadership and guidance of “Mr. Sumit Singla (Proprietor)” we have
been able to achieve the goal of our firm in a well-defined manner. His constant
levels of focus and promise helps us to attain a huge client base.

7
 FACTSHEET

Basic Information

Nature of Business Manufacturer

Additional Business Supplier

Company CEO Sumit Singla

Total Number of Employees 101 to 500 People

Year of Establishment 2011

Legal Status of Firm Sole Proprietorship (Individual)

Company USP

● Experienced R & D Department

Primary Competitive Advantage
● Large Product Line

● Good Financial Position & TQM

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 ● Large Production Capacity

Statutory Profile

Tan No. PTLC1*****

Packaging/Payment and Shipment Details

● Cheque

● DD
Payment Mode
● Cash

Shipment Mode By Road

9
 OUR TEAM

We are backed with an efficient team, which is committed to cater to the diverse
requirements and demands of the clients. Their meticulous and sincere efforts have
enabled us in attaining the maximum satisfaction of the clients. Our team of quality
controllers checks the entire range of the offered machines on various parameters
and hence ensures the optimum quality of offered products.
OUR INFRASTRUCTURE

We have established an innovative and sophisticated infrastructure facility that

sprawls over an extensive area. This infrastructure facility is well-equipped with
ultra-modern machines, tools and equipments to enhance the production capacity.
For flawless and well-defined business operations, we have segregated this
infrastructure facility into numerous departments such as processing department,
quality control department, logistic department, administration department,
research & development department, transportation department and warehousing &
packaging department. All the equipped machines are serviced and lubricated at
regular interval to process the best quality herbal medicines.
WHY US?

Owing to our vast distribution network, flexible payment modes and timely
delivery, we have been able to attain a notable and dynamic position in the market.
The points that help us in staying ahead from other market players are as follows: 

10
 ● Skilled team of professionals
● Well-established infrastructural unit
● Client centric approach
● Ethical business practices
● Wide distribution network
● Pocket-friendly price
● Timely delivery

 Phenylepherine hydrochloride (PPEH) chemically described as (R)-1-(3-

hydroxyphenyl)-2-methylamino ethanol hydrochloride is a sympathomimetic
(alpha-adrenergic) agent 1 who stimulates alpha-adrenergic receptors, producing
pronounced vasoconstriction 2. It is also a frequent constituent of orally
administered nasal decongestant preparations 3. It is officially in IP 1, BP 4 and
USP5.
Cetirizine hydrochloride (CETH) chemically described as [2-[4-[(4-chlorophenyl)
phenyl methyl]-1piperazinyl]ethoxy] acetic acid, dihydrochloride is an
antihistaminic 1, histamine H1 receptor antagonist 4 and an anti-allergic agents
used in the treatment of seasonal rhinitis, hay fever, running nose, control sneezing
of allergic origin 3.
The levorotatory enantiomer of Cetirizine, known as Levocetirizine is more active
form 7. Cetirizine hydrochloride is official in IP 1, BP 4 and USP 5. Literature
survey reveals that several analytical methods have been reported for the
determination of PPEH and CETH as individual and combined dosage form with

11
 each other and with other combination of other drugs such as RP-HPLC,
Spectrophotometric, HPTLC, Fluorimetry and ion-pair Chromatographic method 8-
20
. Our objectives in the present investigation are to develop and validate new RP-
HPLC method for simultaneous determination of PPEH and CETH. The proposed
RP-HPLC method utilise economical solvent system having advantages like better
retention time, very sharp sssand symmetric peak shapes. The proposed method
was validated according to ICH guidelines 6.
Chemical structures of PPEH and CETH: 

1.
2. FIG. 1: CHEMICAL STRUCTURE OF

CETH 
3. FIG. 2:  CHEMICAL STRUCTURE OF PPEHMATERIALS AND
METHOD:Instrument and apparatus:A HPLC Instrument (LC-2010 CHT,
Shimadzu, Japan) equipped with UV detector, auto injector and LC-Solution
Software was used. The chromatographic analysis was performed on Princeton
SPHER C18 Column (250mm x 4.6mm id, 5 μ particle size). Analytical balance

12
(Mettler Toledo), digital pH meter (Eutech instruments pH tutor) was used during
analysis.Reagents and Materials:
Working standards of PPEH (potency = 99.45%) and CETH (potency = 99.12%)
were obtained as a gift samples from Cipla Ltd. Mumbai. HPLC grade
Acetonitrile, AR grades Orthophosphoric acid and Ammonium dihydrogen
phosphate were procured from Merck Ltd. Mumbai India. Water was purified with
Milli-Q Millipore system. All the solvents and solutions were filtered through a
0.45µ membrane filter paper. The commercial fixed dose combination product
Alerid-D tablet (Marketed by Cipla Ltd. Mumbai) containing 10 mg PPEH and 5
mg CETH was procured from the local market.

13
 CHAPTER 2
LITERATURE REVIEW

Guided by pharmacology and clinical sciences, and driven by chemistry, pharmaceutical

research in the past has played a crucial role in the progress of development of pharmaceuticals.
The contribution of chemistry, pharmacology, microbiology and biochemistry has set a standard
in the drugdiscovery where new drugs are no longer generated only by the imagination of
chemists but these new drugs are the outcome of exchange of ideas between biologists and
chemists. The process of drug development starts with the innovation of a drug molecule that has
showed therapeutic value to battle, control, check or cure diseases.

The synthesis and characterization of such molecules which are also called active
pharmaceutical ingredients (APIs) and their analysis to create preliminary safety and therapeutic
efficacy data are prerequisites to identification of drug candidates for further detailed
investigations (Valagaleti et al., 2003). The investigations on the pre drug discovery are based on
knowing the basic cause of the disease to be treated, the information on how the genes are altered
that cause the disease, the interaction of proteins and the affected cells and changes brought by
these affected cells and how they affect these cells. Based on these facts a compound is
developed which interacts with the affected cells and finally could become the drug molecule or
active pharmaceutical ingredient (A.P.I) Drug discovery and Development, understanding the
R&D process(http://www.phrma.org/sites/default/files/159/rd_brochure_022307.pdf).

14
The “compound” which is set to become the drug molecule undergoes safety tests and a series of
experiments to prove that it is absorbed in the blood stream, distributed to proper site of action in
the body, metabolized sufficiently and demonstrates its non-toxicity thus, can be considered safe
and successful. Once the compound is finalized the preclinical research i.e. in vitro studies
followed by the animal testing to check kinetics, toxicity and carcinogenicity tests are performed.
After passing the pre-clinical tests the regulatory authorities grant permission for the clinical
trials. The clinical trials check whether the drug is working in the proposed mechanism or not, its
optimum dose and schedule while the last two stages generate statistically important data about
efficacy, safety and overall benefit–risk association of the drug. In this phase the potential
interaction of the drug with other medicines is determined and monitors drug’s long term
effectiveness. After a successful completion of the clinical trials, the drugs are launched in the
market for patients. 

15
 CHAPTER-3
MATERIAL AND METHODS

Chromatographic Condition:

HPLC system LC-2010 CHT , Shimadzu

Software LC Solution

Detector UV  Detector

Wavelength 225 nm

Pump Isocratic Pump

Princeton SPHER, C18(250 mm x 4.6 mm id,

Stationary phase
5μ particle size)

0.1 M Ammonium dihydrogen phosphate

Mobile phase
buffer (pH 5.2 ± 0.05) : ACN (50:50 v/v)

Flow rate 1.0 ml/min

Injection volume 20 μl

16
Preparation of stock and standard solutions:
A Stock solution of PPEH (1 mg/mL) was prepared by dissolving 100 mg PPEH in
100 ml volumetric flask and volume make up by mobile phase.  CETH (0.5mg/ml)
was prepared by dissolving 50 mg CETH in 100 ml volumetric flask and volume
make by mobile phase. Appropriate volumes of the stock solution were transferred
to appropriate volumetric flask and solution was diluted with mobile phase to
furnish final concentration of PPEH and CETH in the range 10-60μg/ml and 5-
30μg/ml respectively.
Preparation of Tablet dosage form:
20 tablets (Alerid-D Tablet) each contained 10 mg PPEH and 5mg CETH were
accurately weighed.  Their average weight determines and finally powdered. 
Quantity of the powder containing weight equivalent to 100 mg PPEH and 50 mg
CETH were transferred to 100 ml volumetric flask and 50 ml mobile phase was
added followed by ultrasonication for 10 minute and make up the volume up to
100 ml with mobile phase. The resulting solution stirred for 1 hour.  After that
centrifuged at 2000 RPM for 5 minute further dilution was performed with mobile
phase to reach the calibration range for each compound.
Method Validation:
The proposed method was validating according to ICH (Q2) B Guidelines for
validation of analytical procedures.  As per the ICH guidelines the
methodvalidation parameters checked were linearity, accuracy, precision, assay,
robustness, LOD, LOQ.
Linearity (Calibration Curve):
For constructing calibration curve, series of six dilutions in the concentration range
10-60 (10, 20, 30, 40, 50, and 60) μg/ml for PPEH and 5-30 (5, 10, 15, 20, 25, and
30) μg/ml for CETH was taken. Calibration curve were constructed by plotting

17
peak area vs. concentration of PPEH and CETH and regression equation calculated
from calibration curve. Linearity curves have shown in Fig. 5 and 6 respectively.
Accuracy (% Recovery):
The accuracy of the method was determined by calculating recovery of PPEH and
CETH by the standard addition method.  Known amounts of standards solutions of
PPEH and CETH added at 80,100 and 120% level to prequantified sample solution
of PPEH and CETH. Three samples were prepared for each recovery level
solutions were then analysed and the percentage recovery were calculated by using
formula.
Precision:
The precision of analytical procedure express degree of the agreement among
individual test when the procedure is applied repeatedly to multiple sampling of
homogenous samples. Precision are considered at two levels: Repeatability and
Reproducibility.
Method Precision (Repeatability):
The precision of the instrument was checked by repeatedly injecting (n =6)
standard solutions of the PPEH and CETH. Under the same Chromatographic
condition and measurements of % RSD of peak area, retention time, and tailing
factor should not be more than 2%.

Intermediate Precision (Reproducibility):

The intraday and interday precision of the proposed method was determine by
analysing the corresponding responses 3 times of the same day and on three
different days over a period of 1 week for three different concentration of standard
solutions of PPEH (10, 20 and 30 µg/ml) and CETH (5, 10 and 15 µg/ml) the
results were reported in the terms of % RSD.
18
Robustness:
The robustness of the method was established by introducing small changes in
various parameters like, pH of mobile phase, flow rate, wavelength, column
temperature and mobile phase composition. The method was evaluated by
calculating % RSD.
Limit of Detection & Limit of Quantification:
Limit of detection (LOD) was lowest concentration of analyte in the sample that
could be detected under the stated experimental condition and Limit of
quantification (LOQ) the lowest concentration of the active ingredients in a sample
that could be determined with accepted precision and accuracy. According to ICH
recommendation, the approach based on the standard deviation (SD) of the
response and slope (M) was used for determining the detection and quantification
limits. LOD can be calculated according to formula LOD = 3.3 (SD/M) and LOQ =
10(SD/M). The signal to noise ratio was determined. The LOD was regarded as the
amount for which the signal to noise ratio was 3:1 & LOQ as the amount for which
the signal to noise ratio was 10:1.

19
 CHAPTER -4

RESULTS AND DISCUSSION:

To optimize the HPLC parameters, several mobile phase composition were tried.

FIG. 3: CHROMATOGRAM OF PPEH AND CETH IN STANDARD

SOLUTION.

20
A good peak symmetry, a satisfactory resolution for PPEH and CETH was
obtained with mobile phase buffer (pH 5.2 ± 0.05): ACN (50:50 v/v) at a flow rate
1 ml/min to get better reproducibility and repeatedly optimization of method was
done by changing mobile phase composition, pH of mobile phase, column packing,
flow rate, temperature, detection wavelength and the effect on retention and peak
shape were monitored for PPEH and CETH. Typical chromatogram of PPEH and
CETH.

FIG.4: CHROMATOGRAM OF PPEH AND CETH IN SAMPLE

SOLUTION.
1] System suitability test parameters for PPEH and CETH for the developed
method are reported in Table 1.
TABLE 1: SYSTEM SUITABILITY TEST PARAMETERS FOR PPEH &
CETH

CETH ±
Parameters PPEH ± RSD (n=6)
RSD (n=6)

Retention Time (min) 2.19 ± 0.187 4.16 ± 0.104

Tailing Factor 1.42 ± 0.365 1.38 ± 0.373

Theoretical plates 2919 ± 0.316 5004 ±

21
 0.367

9.094 ±
Resolution
0.652

RSD: - Relative standard deviation

2] The method showed good linear response in the concentration range 10-60
μg/ml for PPEH (r2 = 0.9998) and 5-30 μg/ml for CETH (r2 = 0.9998)

FIG.5: LINEARITY CURVE OF PPEH

4.
5. FIG. 6: LINEARITY CURVE OF CETHTABLE 2: REGRESSION
ANALYSIS OF THE CALIBRATION CURVES FOR PPEH & CETH (N=6).

Parameters PPEH CETH

Linear range (µg/ml) 10-60 5-30

Slope 21607 31822

Intercept 15079 524.07

Correlation Coefficient (r2) 0.9998 0.9998

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6. 3] The method was found to be precise and RSD was found to be less than 2% are
given in                  Table 3.

7. TABLE 3: PRECISION OF RP-HPLC METHOD

Interday
Intraday amount found (%)
Drugs Level (n=3) amount found
±RSD (%) ±RSD

100.68±0.682
1 101.63±0.541

  99.25±0.861
2 100.02±1.201
PPEH

98.75±1.652
3 98.92±0.925

  99.56±1.203
1 98.65±0.621
CETH

2 98.95±0.792 100.62±1.652

23
 98.65±0.256
3 99.45±0.994

8. 4] The results of recovery of PPEH and CETH with the RSD less than 2% are
given in Table 4.

9. TABLE 4: RECOVERY STUDIES OF PPEH AND CETH

% Recovery ± % Mean
Drugs Level (n=3)
RSD recovery

80 % 100.96±1.18
   
100 % 100.95±1.88
PPEH 100.47%
120 % 99.50±0.95

80 % 98.43±0.80
   
100 % 98.88±1.13
CETH 99.34%
120 % 100.72±0.18

10.5] Assay of PPEH and CETH shown in Table 5.

11.TABLE 5:  RESULTS OF TABLET ASSAY OF PPEH AND CETH

24
 Amount of %
Drugs Label claim (mg/tab) drug estimated Amount
(mg/tab) found

PPEH 10.0 10.095 100.95

CETH 5.0 4.944 98.88

12.6] LOD and LOQ value of PPEH and CETH was determined by residual standard
deviation method. The results are given in Table 6.

13.TABLE 6: LOD AND LOQ OF PPEH AND CETH

LOQ
Drugs LOD (µg/ml)
(µg/ml)

PPEH 0.176 0.533

CETH 0.248 0.750

14.7] Robustness was evaluated by varying different parameters. The results of these
variations are given in Table 7.
15.ssssss

PPEH CETH
Variatiossss
Parameters Retention Retention
n Assay (%)
time(min) time(min)

25
 0.9 2.44 99.52 4.63

Flow rate(ml/min) 1.0 2.19 100.21 4.16

1.1 1.99 98.56 3.78

5.0 2.19 99.56 4.16

pH 5.2 2.19 99.23 4.16

5.4 2.19 99.98 4.16

24 2.19 100.95 4.16

Column temperature (0C) 25 2.19 99.56 4.16

26 2.19 101.65 4.16

224 2.19 101.85 4.16

Wavelength(nm) 225 2.19 100.90 4.16

226 2.19 99.37 4.16

(60:40) 2.34 101.88 6.34

Mobile Phase
(50:50) 2.19 99.51 4.16
Composition
(40:60) 1.55 98.66 3.88

26
Why it’s used

If you have year-round symptoms, or seasonal allergies like hay fever, your doctor
may recommend cetirizine. Cetirizine may help relieve these allergy symptoms,
but it doesn’t prevent them.

When you come in contact with allergens, your body produces a chemical called
histamine. Histamine causes most of the symptoms related to allergic reactions.
Cetirizine is an antihistamine. It blocks the effects of histamine.

Cetirizine helps relieve mild to moderate allergy symptoms, such as:

● sneezing

27
● runny nose

● itchy or watery eyes

● itchy throat or nose

These reactions can happen after you touch or inhale allergens such as plant pollen,
mold, or pet dander. Allergies usually affect your nose, sinuses, throat, and other
areas of your upper respiratory system.

Cetirizine also helps relieve hives. They are itchy, raised rashes on the skin. Hives
often occur with food or medication allergies.

How to take it

Adults and children 2 years and older can take the syrup, which is fruit flavored.
Adults and children 6 years and older and take the capsules and tablets.

The usual dosage for adults younger than 65 and children who are 6 years and
older is one 10-milligram (mg) dose per day. You shouldn’t take more than 10 mg
in 24 hours. Your doctor may recommend a 5-mg dose once or twice per day if
your allergies are mild.

Talk to your doctor about dosage for people who:

● are 2 to 6 years old

28
● are older than 65 years

● have liver or kidney disease

Cetirizine side effects

Cetirizine is a newer, second-generation antihistamine. Unlike first-generation

antihistamines, cetirizine is less likely to cause side effects such as dangerous
drowsiness, dry mouth, blurred vision, and overheating.

That said, Cetirizine can cause adverse effects, such as:

● drowsiness

● excessive tiredness

● dry mouth

● stomach pain

● diarrhea

● vomiting

Tell your doctor about any unexpected side effects that you have while taking
cetirizine. Also, discuss any ongoing or bothersome side effects. These effects are
usually not emergencies.

Precautions and warnings

Be careful using machinery

29
Even though cetirizine doesn’t usually cause drowsiness, some people respond
differently when taking it, especially in the first few doses. Be cautious, and don’t
drive your car or use machinery until you know for sure how your body will
respond to cetirizine.

Check the ingredients

Don’t use cetirizine if you have ever had an allergic reaction to it or to any of the
ingredients in it. Also, steer clear of cetirizine if you are allergic to any
antihistamine that contains hydroxyzine.

Don’t use during pregnancy and breastfeeding

Talk to your doctor before you take cetirizine if you are pregnant or planning to
become pregnant. Taking cetirizine is generally not recommended during
pregnancy. It’s also not recommended if you breastfeed your child. This is because
the drug passes into breast milk.

Talk to your doctor

If you have liver or kidney disease, ask your doctor about taking cetirizine. If your
doctor feels it is safe for you to take, they may recommend taking less than the
typical dosage.

30
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Interactions with cetirizine

Cetirizine does interact with other substances. For example, avoid consuming
alcoholic drinks while you take cetirizine. Doing so may be dangerous. Mixing
cetirizine with alcohol can cause drowsiness or make you less alert.

If you take any type of tranquilizer, sedative, or sleep aid, make sure to ask your
doctor before you use cetirizine. Mixing cetirizine with drugs that depress your
central nervous system can amplify sedation. It can further impair your mental and
nervous system functions.

There is a possibility of a drug interaction between cetirizine and theophylline.

Theophylline (Theo-24, Theolair) is a drug that some people with asthma and other
lung problems take. However, the interaction is most likely dose-related. It has
only been reported with daily theophylline doses of 400 mg or more. In these
cases, it took longer for cetirizine to leave the body. Talk to your doctor if you take
theophylline and are considering cetirizine.

Cetirizine-D

31
Cetirizine-D and brand-name versions, such as Zyrtec-D, are combination drugs.
The “D” stands for decongestant. These drugs contain both cetirizine and the
decongestant pseudoephedrine.

Your doctor may tell you that cetirizine-D is not for you if you have any of these
conditions:

● heart disease

● thyroid disease

● diabetes

● glaucoma

● high blood pressure

● enlarged prostate with urinary retention

Talk to your doctor

Cetirizine is an over-the-counter drug that can relieve mild to moderate allergy

symptoms. Like any drug, especially over-the-counter medication, you should
understand all of the considerations before you start taking it.

Talk to your doctor about any questions you have about your symptoms and any
other conditions you may have. Your doctor may recommend a different
antihistamine or a combination drug of cetirizine and another product. It may
require a prescription.

Here are a few questions you might ask your doctor about cetirizine:

32
 ● Is cetirizine a good choice for me? What are my options and alternatives?

● How often should I take cetirizine, and how much should I take?

● What effects will I notice after I take cetirizine?

● Can I take cetirizine with my other medications and health conditions?

● Are there any other dangers or risks associated with this medication?

● What are the signs of an emergency, and what should I do in case of an

emergency?

Cetirizine: uses, benefits and side effects

Quick facts
● Cetirizine is also known by the brand name Zirtek.

● 5.5 million items of cetirizine hydrochloride were prescribed by GP surgeries in

England in 2017 (source: openprescribing.net).

Treating allergies with cetirizine

Cetirizine (set-IRI-zeen) is an anti-allergy medicine that belongs to a class of
drugs called second-generation antihistamines. It is used to treat hay fever,
allergic conjunctivitis, eczema, food allergies, insect bites and hives.
The generic version is commonly labelled as cetirizine hydrochloride, which is
the full name of the active ingredient.
The medicine is available both on prescription and over the counter. It comes
either as tablets, capsules and oral liquids.
Cetirizine should be stored in a dry place at 15C to 30C.

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Is cetirizine the same as Benadryl?
Yes and no. The Benadryl brand family (which you’ve probably seen in high-street
pharmacies and supermarkets) actually encompasses a number of different generic
antihistamines. The generic name for the original version of Benadryl is
acrivastine. Benadryl One-a-Day is the cetirizine version of the drug.
To confuse matters somewhat further, there are other over-the-counter brands that
have a cetirizine line, such as Piriteze (which is one of the largest antihistamines by
volume sales). Ask your pharmacist if you have any questions related to the
different types of cetirizine available.
For a more in-depth understanding of the key differences between generic
medicines and brand-name medicines, our article explains all.
Is cetirizine a sleeping pill?
No. Cetirizine is a non-drowsy antihistamine, meaning it’s much less likely to
make you feel sleepy than other types of antihistamine (unless mixed with certain
medications or substances).

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 How does it work?
Like other antihistamines, cetirizine works by blocking the natural
chemical histamine, which gets secreted during an allergic reaction in the body.
Histamine causes the symptoms that are associated with allergy. These include:
● itchy, red, watery eyes

● sneezing

● a runny, itchy nose

● itchy, sometimes visibly red skin.

As an antihistamine, cetirizine counteracts the effects of histamine and helps

relieve you of these symptoms of allergy.
Cetirizine dosage information

Adults take cetirizine once a day, although some children may be directed to take a
smaller syrup dose twice a day. The usual daily dosage of cetirizine for adults
under the age of 65 is 10mg (milligrams) a day.
For children, the typical dose is between 2.5mg and 5mg.

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 The dose you receive will depend on the severity of your allergic reaction. If you
have any questions about the dose you have been given, ask your prescribing GP or
pharmacist.
How and when to take cetirizine
For adults, take cetirizine once a day. It’s up to you what time you take the
medicine - just make sure you stick to roughly the same time every day.
Cetirizine can be taken with or without food. If you are taking cetirizine tablets or
capsules, always take with a glass of water, juice or milk. Swallow them whole and
do not chew.
If you are using oral liquid cetirizine, make sure you use the special measuring
spoon that comes with the medication. Do not use a kitchen spoon, as this can give
you a low or excess dose. If your medication did not come with the measuring
spoon, ask your local pharmacist for a replacement.
Never double dose to make up for a missed dose.
Cetirizine is usually very safe. If you take more than directed, you or your child
may experience common side effects. Contact your GP if you’ve taken too much.
What are the side effects of cetirizine?
Common side effects of cetirizine occur in more than 1 in 100 people. Visit your
GP if you experience any of the following:
● headache

● dry mouth

● feeling sick

● dizziness

● diarrhoea

● cold-like symptoms
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● sore throat

Sore throat is a common side effect of cetirizine.

If these side effects do not improve after a week, then your GP may lower the dose
or take you off the medication altogether.
Cetirizine interactions
According to the NHS, cetirizine can interact with the following medicines when
taken together:
● midodrine, a medicine used to treat low blood pressure;
● ritonavir, a medicine used to treat HIV infection;
● any medicine that makes you drowsy, gives you a dry mouth, or makes it difficult
for you to urinate. Taking cetirizine might make these side effects worse.

A full list of interactions with cetirizine can be found on the NICE website. For

further advice, ask your GP or pharmacist.
Cetirizine contraindications
Cetirizine and alcohol together can make you feel drowsy, so it’s best to lay off the
booze while you take cetirizine.

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 There are some instances where cetirizine may not be suitable to take.
Before taking cetirizine, you should tell your GP if you:
● have a liver, heart or kidney disease

● have urinary retention problems

● have an allergy to peanuts or soya

● have an allergy to the food additives E218 and E216

● have epilepsy or another condition that puts you at risk of seizures

● are pregnant or breastfeeding a child

Cetirizine can also impair mental alertness, so do not drive or operate heavy
machinery when you are taking the medication. If you job requires you to do either
of these, make it a priority to speak to your GP about the situation.
Cetirizine and allergy tests

Cetirizine may interfere with the results of an allergy test, and should be stopped
three days before the taking of the test to get accurate results. If you have an
allergy test planned, do not come off cetirizine without your GP’s consent. Instead,
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consult your GP well in advance of the test to ensure you’ll minimise the chances
of withdrawal symptoms developing when you discontinue the medication.
What’s the easiest way to get cetirizine?
If you’ve been authorised by your GP to take cetirizine on repeat prescription, the
medicine is available for sale over the counter in small pack sizes from pharmacies
and many other retail locations.
Got a busy, hectic weekly schedule? Avoid the last-minute pharmacy dash and
order cetirizine with Echo today.

CONCLUSION

 A validated RP-HPLC method has been developed for the determination of

Phenylephrine Hydrochloride and Cetirizine Hydrochloride in tablet dosage form.
The proposed method is simple, rapid, linear, accurate, precise and specific.
Results from the validation experiments showed that the method is reliable and
accurate therefore it can be successfully applied for the routine quality control
analysis of Phenylepherine Hydrochloride and Cetirizine Hydrochloride in tablet
dosage form Cetirizine

Overview

Cetirizine is an allergy medication that you can buy over-the-counter at a

pharmacy. That is, you don’t need a prescription. The medication comes in
capsules, tablets, and a syrup. You typically take it just once per day, and it begins

39
to work quickly. It’s inexpensive, too — usually less than $1 per day for brand-
name versions (Zyrtec, Aller-Tec, and Alleroff), and even less for generic
products.

Generally, cetirizine is a safe and effective drug, but you should be aware of
certain warnings and precautions when taking this drug. Learn how this drug
works, what it’s used for, and how to take it safely.

REFERENCES

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JG, Mansmann H. Placebo- controlled comparison of cetirizine and hydroxyzine in chronic
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Allergy and Immunology, San Antonio, Feb. 24-Mar. 1, 1989.

2. Allegra L, Paupe J, Wieseman H.G, Baelde Y. Cetirizine for seasonal allergic rhinitis in
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3. Baelde Y. and Dupont P. Cetirizine in Children with Chronic Allergic Rhinitis. A Multicentre
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4(6):455-472. 4. Bousquet J, Duchateau J, et al. Improvement of quality of life by treatment

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6. Broide DH, Love S, Altman R, Wasserman SI. Evaluation of cetirizine in the treatment of
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9. Corren J, Storms W, et al. Effectiveness of Azelastine Nasal Spray Compared with Oral
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10. Day JH, Briscoe M, Rafeiro E, Chapman D, Kramer B. Comparative onset of action and
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