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ISSN 2063-5346
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Method Development and Validation of Cabotegravir by Using HPLC and Characterization of its Degradants by LC-MS

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Bhaskar O. Aher, Sunbee Prakash, Vinod A. Bairagi
» doi: 10.48047/ecb/2023.12.si4.959

Abstract

The characterization and identification of the stressed breakdown products of cabetogravir (CBT) were accomplished by development and validation of a rapid, precise, and dependable isocratic LC-MS approach. According to the parameters established by the International conference on Harmonisation, the antiviral medication CBT was submitted to hydrolysis in acidic, alkaline, and neutral solutions as well as to oxidation, photolysis, and thermal stress. Under acid hydrolysis and oxidative stress conditions, the drug showed less degradation. But it remained stable in the presence of thermal, wet heat, photolysis stresses. Five different degradation products in total were identified, and the drug and these products were separated chromatographically on a Kinetex C18 column (250 4.6 mm, 5 m) using a mobile phase of 20 mM (pH 3), 70:30 v/v, methanol and phosphate buffer. By using LC-MS, the degradation products were identified, and their fragmentation paths have been proposed. With regard to specificity, linearity, accuracy, and precision, the LC-MS method was validated.

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