Journal of Pharmaceutical Analysis and Drug Research ISSN: 3108-0839 (Online)

Authors: Anuradha Chaturvedi, Priyanka Pathak

Abstract: The accurate and reliable quantification of active pharmaceutical ingredients (APIs) is crucial in the pharmaceutical industry to ensure the safety, efficacy, and quality of pharmaceutical products. This paper focuses on the development and validation of analytical methods for the quantification of APIs, which play a key role in pharmaceutical research, development, and manufacturing processes. The paper provides an overview of the importance of analytical methods, discusses the challenges encountered during their development, and presents the validation process for ensuring their reliability and compliance with regulatory requirements. Various analytical techniques employed for API quantification, such as spectroscopy, chromatography, and electrochemical methods, are discussed, highlighting their principles, advantages, and limitations. Additionally, the paper addresses the parameters involved in method validation, including accuracy, precision, linearity, range, specificity, and robustness. The significance of reference standards, calibration curves, and quality control samples in method validation is also emphasized. Overall, this paper serves as a comprehensive guide for researchers, analysts, and scientists involved in the development and validation of analytical methods for the quantification of APIs.

Keywords: Active Pharmaceutical Ingredients (APIs), UV-Vis, HPLC, GC, TLC, Quality control samples