ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DOLUTEGRAVIR AND LAMIVUDINE IN TABLET DOSAGE FORM BY RP-HPLC

Dr. Sonali P. Mahaparale* and Jayraj U. Deshmukh

ABSTRACT

A Novel reversed phase high performance liquid chromatographic method was developed and validated for the simultaneous determination of human immune deficiency virus drug Dolutegravir (DGV) and Lamivudine(LMD) present in formulation known as Dovato which consists 50 mg of DGV and 300 mg LMD. Chromatographic separation achieved isocratically on thermo C18 column (5μm, 150mm x 4.60mm) and Acetonitrile Water(pH 5) in the ratio of 50:50 (v/v) as the mobile phase, at a flow rate of 0.8 ml/min. Detection was carried out at 267 nm. The retention times for DGV and LMD was found to be 2.56 min and 6.7 min respectively. Parameters like linearity, precision, accuracy, recovery, specificity and ruggedness are studied as reported within the ICH guidelines. The method was linear in the concentration range of 25-75 μg/ml for (DGV) and 150-450 μg/ml for (LMD). Correlation coefficient of Dolutegravir and Lamivudine was found to be 0.999 and 0.998 respectively. Developed method was found to be novel, accurate, precise, selective and rapid for simultaneous estimation of DGV and LMD.

Keywords: Reverse Phase, Isocratic elution, Linearity, Chromatographic separation.