Abstract

A REVIEW ON ANALYTICAL PROFILE FOR NEWLY FDA APPROVED DRUGS IN 2022

P. Siva Krishna*, M. M. Eswarudu, P. Srinivasa Babu, T. Likhitha, N. Venkatesh, Ch. Poojitha, K. Srujana and B. Gopaiah

ABSTRACT

The year 2022 witnessed a remarkable surge in the development and approval of novel pharmaceutical entities by United States Food and Drug Administration (USFDA). The successful translation of these new chemical entities into clinical practice relies heavily on the implementation of robust analytical methods for their characterization, quality control, and regulatory compliance. This review article presents a brief review process of USFDA approved drugs, analytical methods for the systematic approaches used to qualitative and quantitative analysis of drug substances and drug profiles of selected approved drugs in 2022, with a primary focus on High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC) hyphenated techniques like Liquid Chromatography-Mass Spectrometry (LC-MS). The central theme of this review revolves around the pivotal role that analytical methods play in ensuring the safety, efficacy, and quality of pharmaceutical products. It highlights the versatility of HPLC in quantification and separation of drug compounds, shedding light on its diverse applications in analysing complex formulations. UPLC, known for its enhanced resolution and shorter analysis time, emerges as an indispensable tool for fast-paced drug analysis. Furthermore, the integration of mass spectrometry into liquid chromatography workflows (LC-MS) enables the identification of drug metabolites and impurities with unparalleled sensitivity and selectivity.

Keywords: USFDA, HPLC, UPLC, LCMS, APA and Biological Samples.