Simultaneous Determination of Dolutegravir and Lamivudine in Human Plasma by LC-MS/MS

A rapid, simple, sensitive and selective LC-MS/MS method has been developed validated for quanti? cation of the Dolutegravir Lamivudine in plasma samples. The analytical procedure involves a liquid–liquid extraction using Emtricitabine as an internal standard (IS). precision accuracy data have to fulfill requirements quantification analytes biological matrices generate bioequivalence bioavailability investigations. chromatographic separation was achieved on Hypurity Advance (4.6, 50 mm, 5μ) column mobile phase consisting 0.1% formic acid buffer–acetonitrile (20:80, %v/v) at ? ow rate 0.8 mL/min. API- 4000 operated multiple-reaction monitoring mode electrospray ionization. total run time analysis 3 min elution Dolutegravir, (IS) occurred 1.06, 1.84 0.92 min, respectively. detailed validation performed per US Food Drug Administration guidelines. terms linearity, accuracy, precision, specificity, limit detection quantitation. curves found be linear range 0.10–30.0 ng/mL 20.2–6026 Lamivudine, with coef? cient correlation =0.99 both compounds. were stable stability studies, viz. bench-top, autosampler, re-injection, wet-extract repeated freeze– thaw cycles. coefficient variation =15% intra- inter-batch assays. assay is suitable pharmacokinetic study samples demonstrated by its recovery, characteristics.