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    This document describes the development and validation of UV spectroscopic methods for the simultaneous quantification of dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride in bulk and tablet dosage forms. The methods developed were the simultaneous equation method and Cramer's matrix method. Both methods were validated based on parameters such as specificity, linearity, accuracy, precision, limit of detection, and limit of quantification. The concentrations obtained from the two methods were comparable, demonstrating their suitability for the simultaneous analysis of the three drugs.

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    PROJECT

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    This document describes the development and validation of UV spectroscopic methods for the simultaneous quantification of dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride in bulk and tablet dosage forms. The methods developed were the simultaneous equation method and Cramer's matrix method. Both methods were validated based on parameters such as specificity, linearity, accuracy, precision, limit of detection, and limit of quantification. The concentrations obtained from the two methods were comparable, demonstrating their suitability for the simultaneous analysis of the three drugs.

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    This document describes the development and validation of UV spectroscopic methods for the simultaneous quantification of dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride in bulk and tablet dosage forms. The methods developed were the simultaneous equation method and Cramer's matrix method. Both methods were validated based on parameters such as specificity, linearity, accuracy, precision, limit of detection, and limit of quantification. The concentrations obtained from the two methods were comparable, demonstrating their suitability for the simultaneous analysis of the three drugs.

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    118 views21 pages

    PROJECT

    Uploaded by

    HARI HARA RAO GUJJAR
    This document describes the development and validation of UV spectroscopic methods for the simultaneous quantification of dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride in bulk and tablet dosage forms. The methods developed were the simultaneous equation method and Cramer's matrix method. Both methods were validated based on parameters such as specificity, linearity, accuracy, precision, limit of detection, and limit of quantification. The concentrations obtained from the two methods were comparable, demonstrating their suitability for the simultaneous analysis of the three drugs.

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    of 21

    METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION

    OF DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE AND


    PHENYLEPHRINE HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORM BY UV
    SPECTROPHOTOMETRY
    project Submitted to
     

    JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY, ANANTAPUR


    In the partial fulfilment for the award of degree of

    BACHELOR OF PHARMACY
     
    Submitted by
    Under the guidance of A SUNANDA(15421R0001)
    Smt. P. KEERTHI SIKHA, M. Pharm.(Ph.D) A JAMUNA(15421R0003)
    Assistant Professor G KUMAR(15421R0022)
    G HARI HARA RAO(15421R0023)
    Department of Pharmaceutical Analysis M JYOTHI(15421R0034)
    MS BHASKAR(154210038)

    SRI PADMAVATHI SCHOOL OF PHARMACY


    MOHAN GARDENS, TIRUCHANOOR-517503 (A.P.)
    INDIA
    APRIL2019
    CONTENTS
    RATIONALE FOR THE PROJECT WORK

    REVIEW OF LITERATURE

    OFFICIAL METHODS

    ANALYTICAL METHODS REPORTED ON SELECTED FDC(fixed dose combination)

    AIM &OBJECTIVES

     EXPERIMENTAL WORK AND RESULTS

    SIMULTANEOUS EQUATION METHOD

    CRAMER’S MATRIX METHODS

    VALIDATION PARAMETERS

    COMPARISON OF SIMULTANEOUS EQUATION AND CRAMER’S MATRIX METHODS

    CONCLUSION

    REFERENCES
    RATIONALE FOR THE PROJECT WORK

    FDC IMPORTANCE
    Improved patient compliance
    Better efficacy
    Improved ADME
    Safety
    Good quality

    Need for the development of


    analytical methods
    REVIEW OF LITERATURE
    Selection of FDC

    Dextromethorphan HBr + chlorpheniramine maleate+ phenylephrineHCl

    LABEL CLAIM
    BRAND NAME
    Dex-10mg TUSQ-DX
    Cpm-2mg Manufacturing
    company
    Phe-5mg
    Bluecross
    laboratories

    Selection of analytical methods


    1)Simultaneous equation methods 2) cramer’s matrix method
    OFFICIAL METHODS
    DRUGS IP BP USP

    1) Dextromethorphan HBr Acid Base titrations Acid Base titrations HPLC

    2) Dextromethorphan HBr HPLC --------------------------- HPLC

    syrup

    3) Chlorpheniramine maleate Non aqueous titrations Non aqueous titrations Non aqueous titrations

    4) Chlorpheniramine maleate UV-spectrophotometry UV-spectrophotometer UV-spectrophotometer

    injection

    5) Phenylephrine HCl Acid Base titrations Acid Base titrations Redox titrations(idometry)

    6) Phenylephrine injection UV-spectrophotometry UV-spectrophotometry HPLC

    7) Phenylephrine eye drops ---------------------- HPLC ---------------------


    ANALYTICAL METHODS REPORTED ON
    SELECTED FDC
    TITLE AUTHOR JOURNAL PUBLISHED WORK REPORTED

    ANALYTICAL METHOD DEVELOPMENT AND Kapildev R. Jaiswal 2016 RP-HPLC


    VALIDATON OF RP-HPLC FOR SIMULTANEOUS
    ESTIMATION OF CHLORPHENIRAMINE MALEATE,
    DEXTROMETHORPHEN HYDROBROMIDE,
    PHENYLEPHRINE HYDROCHLORIDE IN COUGH
    SYRUP

    SIMULTANEOUS ESTIMATION OF PHENYLEPHRINE S. Ashutosh Kumar, 2016 RP-HPLC


    HCL, CHLORPHENIRAMINE MALEATE AND
    DEXTROMETHORPHAN HBR IN A Manidipa Debnath,
    PHARMACEUTICAL ( SYRUP ) FORMULATIONS BY
    RP-HPLC USING PDA DETECTOR
    D. Vimala

    SIMULTANEOUS DETERMINATION OF Nora H.Al-Shaalan 2012 RP-HPLC


    CHLORPHENIRAMINE MALEATE,
    DEXTROMETHORPHAN HBr AND PHENYL EPHRINE
    IN CODILARSYRUP USING HIGH PERFORMANCE
    LIQUID CHROMATOGRAPHY
    AIM AND OBJECTIVE

    The aim of the present work was to develop and validate simple and economical UV spectrophotometric methods for
    quantitative estimation of Dextromethorphan hydrobromide, Phenylephrine hydrochloride and Chlorpheniramine maleate in
    bulk and tablet dosage form.
    EXPERMENTAL WORK AND RESULTS
    solubility studies:

    Drugs Solvent Observations


    Dextrometharophan water Partially soluble
    hydrobromide
    0.1MNaOH Insoluble
    0.1N HCL insoluble
    Chlorpheniramine maleate water Freely soluble
    0.1MNaoH Partially soluble
    0.1N HCL Freely soluble
    Phenylephrine hydrochloride water Freely soluble

    0.1MNaoH Freely soluble


    0.1N HCL Freely soluble
    Determination of λ Max:
    Dextromethorphan hydrobromide: Phenylephrine hydrochloride: Chlorpheniramine maleate

    λMAX=278nm λMAX=273nm λMAX=261.4nm


    CALIBRATION GRAPHS OF OF DEX, PHE AND CPM
    DEX(0.4-2mcg\ml) PHE(0.2-1mcg\ml) CPM(0.1-0.7mcg\ml)

    1 Chart Title

    Absorbance
    0.9
    f(x) = 0.01 x + 0
    0.8 R² = 1
    0.7
    0.6
    0.5
    0.4 Linear ()
    0.3
    0.2
    0.1
    0
    0 10 20 30 40 50 60 70 80
    Concentration
    SAMPLE PREPARATION

    20 tablets were accurately weighed and triturated.

    Take required quantity of powder it is equivalent to 10mg of Dex,mg of Phe,and 2mg of Cpm.

    Then added into 50ml of standard flask

    Samples were dissolved using 15ml distilled water and fill upto the mark

    Samples were kept into sonicator for15 minutes

    Filtered

    Take 4ml of filtrate and dilute to 10ml

    Get concentration of 80mg,of Dex 40mg of Phe,16mg of Cpm.


    UV SPECTROSCOPIC METHODS
    SIMULTANEOUS EQUATION METHOD CRAMER’S MATRIX METHOD
    • If a sample contains two absorbing drugs, Cramer’s matrix method uses for the application
    each of which of absorbs at the λmax of the of cramer’s rule.
    other, then both the drugs can be determine
    by this technique.
    • The λmax of two component should be In this the matrix is formed by tacking the molar
    reasonably dissimilar. absorptivities of the drugs at their respective
    absorption maxima.
    • The two component should not interact
    chemically.
    Simultaneous equation method:
    ••  If a sample contains three absorbing drugs [X, Y and Z ] each of which absorbs at the λmax of the other, it may
    be possible to determine three drugs by the technique of simultaneous equations

     
    RESULTS
    Dextromethorphan Phenylephrine hydrochloride Chlorpheniramine maleate(Z)
    hydrobromide ( X) (Y)

    ax1 ax2 ax3 ay1 ay2 ay3 az1 az2 az3

    0.004558 0.003802 0.0016 0.008543 0.009085 0.004875 0.001390 0.004090 0.01336

    Absorbances in test sample:


    A1= 0.704 CX=79.666
    A2 = 0.710 CY=37.000
    A3= 0.537 CZ=17.088
    Cramer’s matrix method:

    Cramer’s matrix method uses for the application of Cramer’s rule.


    Am1x1 Cz Cyz,1 Cx Cy y,1 Cx Cz

    Am2x,2 Cz Cyz,2 Cx Cy y,2 Cz Cx

    Am3x,3 Cz Cyz,3 Cx Cy y,3 Cx Cz

    Where, Am = Absorbance of sample.

    ε = Molar absorptivity of three drugs X,Y and Z.


    C = Concentration of X,Y and Z drugs at λ1,λ2 and λ3

    respectively.
    METHOD VALIDATION PARAMETERS

    SPECIFICITY

    LINEARITY
    ACCURACY AND RANGE

    Analytical
    Method
    Validation
    LIMIT OF
    QUANTITATIO
    N PRECISION

    LIMIT OF
    DETECTION
    COMPARISION THE VALUES OF SIMULTANEOUS EQUATION
    METHOD AND CRAMER’S MATRIX METHOD

    SIMULTANEOUS EQUATION METHOD CRAMER’S MATRIX METHOD

    CX=79.666 CX=79.65

    CY=37.000 CY=37.01

    CZ=17.08
    CZ=17.088
    CONCLUSION

     The UV-Spectrophotometric methods like Simultaneous equation method and Cramer’s matrix method

    were developed for the quantitative estimation of Dextromethorphan hydrobromide,Phenylephrine

    hydrochloride and Chlorpheniramine maleate and they were found to be simple, accurate, rapid, sensitive and

    economical. The developed methods were validated as per the ICH guidelines.

    The developed simultaneous equation and Cramer’s matrix methods can be used for the regular analysis of

    Dextromethorphan hydrobromide, Phenylephrine hydrochloride and Chlorpheniramine maleate in Quality

    control laboratories.
    REFERENCE

    • G.Vidya Sagar, Basics of drug analysis, 2nd Ed.,p.1-2 PharmaMed Press Pvt.Ltd,2011
    • P.D Chaitanya Sudha, Pharmaceutical Analysis, 1st Ed., p.1, Dorling kindersely Pvt.Ltd.,2013
    • David Harvey, Modern analytical chemistry, 1st ed. McGraw-Hill; 2000; p. 5-9.
    • Willard HH, Merritt LL, Dean JJA, Frank AS. Instrumental methods of analysis, 7th Ed., CBS Publishers and Distributors,
    New Delhi, 1986.
    • James W. Robinson. Undergraduate instrumental analysis. 6th ed. Marcel Dekker, 2005; p. 329-45.
    • Donald L.Pavia, Gary M. Lampman, George s.kriz, Introduction to Spectroscopy 4th Ed., p.353-354,2010
    • Y.R Sharma, Elementary organic spectroscopy:Principles and applications 5th Ed,2016; p.56-58
    • James W. Robinson. Undergraduate instrumental analysis. 6th ed. Marcel Dekker, 2005; p. 329-345.
    • Gurdeep R Chatwal, Sham K Anand, Instrumental methods of chemical analysis 5 th Ed p.2.171-2.172
    • Y.R Sharma, Elementary organic spectroscopy:Principles and applications 5th Ed;2016;p.56-58
    • P.D Chaitanya Sudha, Pharmaceutical Analysis, 1st Ed.,2013; p.1, Dorling kindersely Pvt.Ltd p.219-220
    • A.H. Beckett, J.B. Stenlake. Practical pharmaceutical chemistry. 4th ed. Part two. CBS Publishers & Distributors Pvt Ltd;
    2007; p.284-286.
    • www.pubchem.com/ Dextromethorphan Hydrobromide

    • www.pubchem.com/ Chlorpheniramine Maleate

    • www.pubchem.com/ Phenylephrine Maleate

    • Kapildev.jaiswal “Analytical method development and validation of RP-HPLC for simultaneously estimation of
    Chlorpheniramine maleate,Dextromethorphan hydrobromide, Phenylephrine hydrochloride in cough syrup” International
    Journal of Advances in Science Engineering and Technology Volume- 4,

    • S. Ashutosh Kumar, Manidipa Debnath , D. Vimala “Simultaneous estimation of phenylephrine HCl, chlorpheniramine
    maleate and dextromethorphan HBr in a pharmaceutical (syrup) formulations by RP-HPLC using PDA detector”Pakistan
    journel of Pharmaceutical research Vol:02,Issue:02PP:89-97

    • Nora H AL Shaalan “Simultaneous estimation of phenylephrine HCl, chlorpheniramine maleate and dextromethorphan HBr
    in a pharmaceutical (syrup) formulations by RP-HPLC using PDA detector ; Journel of pharmaceutical and scientific
    innovation JPSI JAN-FEB 2012,29-32.

     
    THANK YOU

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