Abstract

ANALYTICAL AND BIOANALYTICAL METHODS FOR THE ESTIMATION OF ANTI-HIV DRUGS TENOFOVIR DISPROXIL FUMARATE AND EMTRICITABINE: A CRITICAL REVIEW

Debarya Banerjee, Dr. J.S.K. Nagarajan*, Shambhavi Shahi, Rudranil Karmakar, Ramakrishna Raja and Logeshwaran M.

ABSTRACT

Drug analysis and clinical trials depend heavily on the development and validation of analytical and bio-analytical methods, particularly when emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) determinations are involved. We provide an abstract of the analytical and bio-analytical techniques created and approved for the measurement of these medications in this investigation. We conducted a thorough literature review to determine the best procedures, and then we optimised and verified them in accordance with the International Conference on Harmonisation (ICH) standards. To quantify emtricitabine (FTC) and Tenofovir disproxil fumarate (TDF), the developed methods used a variety of chromatographic methods, such as high-performance liquid chromatography (HPLC) and liquid chromatography-tandem mass spectrometry (LC-MS/MS), Ultra-Performance Liquid Chromatography (UPLC), UV Spectroscopy. It was established that these techniques have good linearity, accuracy, precision, and specificity, limit of detection, limit of quantification, however in some articles some information like retention time, LOD,LOQ were missing . Additionally, they demonstrated sensitivity and selectivity for quantifying the analytes in biological matrices such plasma, dried blood spots, and breast-milk. Overall, the developed analytical and bio-analytical procedures may produce accurate and trustworthy results for the quantification of Emtricitabine (FTC) and Tenofovir disproxil fumarate (TDF), making them useful instruments for therapeutic medication monitoring, pharmacokinetic research, and bioequivalence studies.

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