RP-HPLC method for swift analysis of Lamivudine and Dolutegravir in formulation, stability studies

Abstract

New RP-HPLC method have been developed for simultaneous analysis of lamivudine and dolutegravir in pharmaceutical dosage forms and applied to stability studies of drugs. The title analytes were eluted rapidly with phosphate buffer (pH 5.0) and acetonitrile (60:40 v/v) on Std discovery C18 (150 x 4.6 mm, 5 µ) column. The detection was carried out using PDA detector at 260 nm. The solutions were chromatographed at a constant flow rate of 1 mL/min. Lamivudine and Dolutegravir were eluted at 2.37 min and 2.97 min respectively with good resolution. Method was validated as ICH guidelines. The linearity range of lamivudine and dolutegravir were found to be of 18.75 - 112.5 µg/mL and 3.125 - 18.75 µg/mL, respectively. The % RSD values (< 2) in precision studies indicates the reproducibility of method. The percentage recoveries were 100.17 % and 100.36 % respectively for lamivudine and dolutegravir, found to be within the limits. The proposed validated method was fruitfully applied for assay of formulation and stability studies of drugs under various stress conditions.