STABILITY INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE AND DOLUTEGRAVIR IN BULK AND TABLET DOSAGE FORM

Abstract

A rapid high-performance liquid chromatographic method has been developed and validated for quantification of lamivudine and dolutegravir, used to manage HIV infections. Lamivudine and dolutegravir are separated as symmetrical peaks on the analytical column Inertsil ODS, 150 mm x 4.6 mm, 5.0 µm using 50 % acetonitrile and 50 % triethylamine buffer as mobile phase and detected by photo diode array detector at wave length 250 nm. The total chromatographic runtime is 6.0 min with retention times for lamivudine and dolutegravir at 2.457 and 3.888 min, respectively. The method was validated according to ICH guidelines and linear calibration curves were obtained across a range of 6.01-90.15 µg mL-1 and 1.01 -15.15 µg mL-1 for lamivudine and dolutegravir, a correlation coefficient of R2 0.999. Tablets containing lamivudine and dolutegravir were subjected to acid hydrolysis, alkali hydrolysis, oxidising agent, reducing agent, heat and UV light at two variable conditions and the drugs peaks are well resolved. This developed method can be used routinely for the determination of lamivudine and dolutegravir in bulk and tablet dosage form.