A Note On Modern Pharmaceutical Analysis

Research & Reviews: Journal of Pharmaceutical Analysis e-ISSN:2320-0812
A Note on Modern Pharmaceutical Analysis
Rowan Clem*
Department of Pharmacology and Toxicology, University of California, California, USA
Editorial
Received: 24-Jan-2022,
EDITORIAL NOTE
Manuscript No. JPA-22-52346;
Editor assigned: 26-Jan-2022, Pharmaceutical analysis is a discipline of practical chemistry that
PreQC No. JPA-22-52346(PQ); encompasses a set of procedures for identifying, determining, quantifying,
Reviewed: 07-Feb-2022, QC No. and purifying a substance, as well as separating the components of a
JPA-22-52346; Accepted: 09-Feb- solution or mixture and determining the structure of chemical compounds. It
2022, Manuscript No. JPA-22- might be a single ingredient or a combination of compounds, and it could
52346(A); Published: 16-Feb- come in any dosage form. Animals, plants, microorganisms, minerals, and
2022, DOI:10.4172/2320- different synthetic materials are the substances that are utilised as
0812.11.01.e001 pharmaceuticals.
*For Correspondence:
Rowan Clem, Department of
Pharmacology and Toxicology,
University of California, California,
USA
E-mail: [email protected]
Modern pharmaceutical analysis entails much more than the evaluation of Active Pharmaceutical Ingredients
(APIs), inert substances (excipients), and finished Drug Products (DP). Pharmaceutical analysis' main purpose is to
ensure drug quality. Quality cannot be tested into a product; nevertheless, well-planned testing using appropriate
methods and instrumentation can aid in the development of a DP's quality.' It's critical to have a complete grasp of
how pharmacological compounds interact with excipients, especially when residual solvents (including moisture)
are present. Understanding potential degradation reactions in the formulated product under various stress
conditions that may be experienced during storage and shipment of the final package is also critical. Dissolution
tests should also be in excellent accordance with bioavailability. In a brief, the goal of pharmaceutical analysis is to
assist in the development and assurance of DP quality. The Food and Drug Administration (FDA) has issued the new
Quality by Design (QbD) project, which is defined in the "Pharmaceutical Quality for the Twenty-First Century: A Risk-
based approach". This concept's main point is that quality should be built into a product by a deep understanding of
RRJPA| Volume 11 | Issue 1 |January, 2022 1

the product and the development and production process, as well as knowledge of the risks involved in making the
product and how to best minimise those risks through continuous product improvement [1].
Modern Pharmaceutical Analysis discusses QbD as well as other recent advancements such as the best
approaches to monitor Genotoxic Impurities (GTIs), chiral chemical separations, and biopharmaceutical protein
identification and analysis [2]. It covered a variety of separation methods used in the pharmaceutical industry for the
evaluation of a wide range of samples during the drug development process, including Capillary Electrophoresis
(CE) [3], Thin Layer Chromatography (TLC), Gas Chromatography (GC) and High-pressure or High-Performance Liquid
Chromatography (HPLC) with a focus on analytical chemistry's involvement. These approaches are still the
alternatives to use when verifying the purity of new drug candidates, monitoring modifications or scaling up
synthetic procedures, evaluating new formulations, and ensuring the quality of final DPs. For detecting
contaminants, hybrid approaches that combine chromatographic procedures with spectroscopic methods such as
Mass Spectrometry (MS) or Nuclear Magnetic resonance (NMR) have been proven to be beneficial [4-8]. The goal of
modern pharmaceutical analysis is to take into account a variety of essential standards as well as new initiatives
aimed at improving DP quality. Using the most up-to-date analytical technologies, we can achieve higher sensitivity
and selectivity [9]. Methods for monitoring Gib are included, as well. The consequences for pharmaceutical analysis
based on the new "Quality by Design" paradigm are highlighted [10]. As biopharmaceutical proteins become more
important, this course will cover their characterization and analysis. The important elements of modern
pharmaceutical analysis are providing up-to-date information on documentation in light of regulatory guidelines,
technology, and industry trends.
REFERENCES
1. Schneider B B, et al. Chemical effects in the separation process of a differential mobility/mass

spectrometer system. Anal Chem, 2010; 82:1867-1880.
2. Xia Y Q, et al. Differential mobility spectrometry combined with multiple ion monitoring for bioanalysis of
disulfide-bonded peptides with inefficient collision-induced dissociation fragmentation. Bioanalysis. 2017;
9:183-192.
3. Ha PTT, et al. Recent advances in pharmaceutical applications of chiral capillary electrophoresis. J Pharm
Biomed Anal. 2006;41:1-11.
4. Adams E, et al. Optimization and validation of liquid chromatography and headspace-gas chromatography
based methods for the quantitative determination of capsaicinoids, salicylic acid, glycol monosalicylate,
methyl salicylate, ethyl salicylate, camphor and l-menthol in a topical formulation. J. Pharm. Biomed. Ana.
2012;60:51-58.
5. Valdez JS, et al. Sensitive and selective gas chromatographic methods for the quantitation of camphor,
menthol and methyl salicylate from human plasma. J. Chrom. B. 1999;729:163-171.
6. Bahjat KS, et al. Determination of camphor and menthol in pharmaceutical products by gas
chromatography. J. Pharm. Sci. 1963;52:1006-1007.
7. Tan HIS, et al. Gas-liquid chromatographic assay of mixtures of camphor, menthol and methyl salicylate in
ointments. J. Chrom. 1982;238:241-246.

8. Kim E, et al. Simultaneous determination of 3-O-acetyloleanolic acid and oleanolic acid in rat plasma using
liquid chromatography coupled to tandem mass spectrometry. J Pharm Biomed Anal. 2016; 118:96-100.
9. Loos G, et al. Quantitative mass spectrometry methods for pharmaceutical analysis. Phil. Trans. R. Soc. A.
2016;374.
10. Yu LX, et al. Understanding pharmaceutical quality by design. AAPS J. 2014;16:771-783.

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Research & Reviews: Journal of Pharmaceutical Analysis e-ISSN:2320-0812

A Note on Modern Pharmaceutical Analysis

Department of Pharmacology and Toxicology, University of California, California, USA

RRJPA| Volume 11 | Issue 1 |January, 2022 1

1. Schneider B B, et al. Chemical effects in the separation process of a differential mobility/mass

RRJPA| Volume 11 | Issue 1 |January, 2022 2

RRJPA| Volume 11 | Issue 1 |January, 2022 2

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