Abstract:

A simple, specific and accurate reverse phase ultra-performance liquid chromatographic method was developed for the simultaneous determination of Dolutegravir and Lamivudine in pharmaceutical dosage form. The column used was ACQUITY UPLC BEH C18 column (2.1 mm x 50 mm, 1.7 μm) in isocratic mode, with mobile phase containing Acetonitrile: Phosphate buffer pH (3.0) (50:50). The flow rate was 1.2 ml/min and effluents were monitored at 260 nm. The retention times of Dolutegravir and Lamivudine were found to be 1.430 min and 2.347 min, respectively. The linearity for Dolutegravir and Lamivudine were in the range of 100-300 μg/ml and 10–50 μg/ml respectively. The recoveries of Dolutegravir and Lamivudine were found to be 98.13% to 98.89% and 99.6 to 101% respectively. The proposed method was validated and successfully applied to the estimation of Dolutegravir and Lamivudine in combined tablet dosage forms. Therefore, a sensitive, robust, accurate method with high degree of sensitivity was developed for practical utility.

Description:

Dolutegravir, Lamivudine, Validation, Buffer and ICH Q2 (R1) guidelines.