Ravindra puppala, N. Subbaiah, K. S. Maheswaramma
2022
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Journal
RASAYAN Journal of Chemistry
Abstract
A selective and sensitive novel method was established and validated for well-characterized tert-butyl ((1S, 3R)-3- acetylcyclopentyl) Carbamate (Acetyl BOC) and tert-butyl (1S, 3R)-3-hydroxycyclopentyl) Carbamate (Hydroxy BOC) genotoxic impurities in Bictegravir sodium active pharmaceutical ingredient by using liquid chromatographytandem mass spectrometry. The developed method was more accurate and capable to confirm the m/z values of parent and fragment ions, method was validated through ICH guidelines to detect 0.3 ppm and estimate up to 1.0 ppm of both impurities. The correlation coefficient was observed > 0.9993 and the recovery percentage of genotoxic impurities was found to be between 93% to 108%.