ABSTRACT A simple, sensitive, and selective LC–MS/MS method has been developed and validated, in accordance with ICH M10 guidelines, for the simultaneous quantification of Bictegravir (BTV), Emtricitabine (ECB), and Tenofovir alafenamide (TAM) in human plasma. Following a straightforward solid‐phase extraction, the analytes were separated using a reverse‐phase C18 column with an isocratic mobile phase consisting of 10 mM ammonium acetate (pH 3.0), acetonitrile, and methanol in a 30:10:60 (v/v/v) ratio. The method demonstrated linear dynamic ranges of 25–1600 ng/mL for BTV, 10.0–6120.1 ng/mL for ECB, and 2.0–803.78 ng/mL for TAM, utilizing a low plasma volume of 200 µL and an injection volume of 5 µL. The validated method has been successfully applied to the analysis of plasma samples from healthy male subjects in pharmacokinetic (PK), bioavailability, and bioequivalence studies of BTV/ECB/TAM tablets (50 mg/200 mg/25 mg). Additionally, the method is suitable for therapeutic drug monitoring, PK evaluations, bioequivalence and bioavailability assessments, toxicity studies, human immunodeficiency virus (HIV) reservoir investigations, and stringent quality control in pharmaceutical manufacturing.
Kumar et al. (Wed,) studied this question.