Development and Validation of Analytical Methods for Pharmaceutical Drug Products

Harshavardhan Tanpure¹ , Jirekar D.B.²

Section:Research Paper, Product Type: Journal-Paper
Vol.11 , Issue.5 , pp.92-94, Oct-2024

Online published on Oct 31, 2024

Copyright © Harshavardhan Tanpure, Jirekar D.B. . This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
 

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Abstract :
This paper focuses on the development and validation of analytical methods to ensure the quality, efficacy, and safety of pharmaceutical drug products. The study covers various analytical techniques, including High-Performance Liquid Chromatography (HPLC), Ultraviolet-Visible (UV-Vis) Spectroscopy, and Mass Spectrometry (MS), and their application in the quantitative analysis of active pharmaceutical ingredients (APIs). A case study on a model drug, Paracetamol (C8H9NO2), is presented to demonstrate the process of method development and validation. Stability studies were also conducted to evaluate the degradation profile of the drug under different conditions.

Key-Words / Index Term :
Analytical Methods, Pharmaceutical Drugs, Method Validation, High-Performance Liquid Chromatography, Paracetamol, Stability Studies

References :
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[4] ICH Q1A(R2) Stability Testing of New Drug Substances and Products, International Conference on Harmonisation, 2003.
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[8] Snyder, L. R., Kirkland, J. J., & Dolan, J. W. Practical HPLC Method Development, 2nd Edition, John Wiley & Sons, 2010.
[9] United States Pharmacopeia (USP) 42-NF 37, General Chapters: Validation of Compendial Procedures, United States Pharmacopeial Convention, 2019.