Simultaneous Estimation of Lamivudine and Stavudine by using RP-HPLC and Method Development as per ICH Guidelines

A simple, rapid and accurate reverse phase-high performance liquid chromatographic method for the simultaneous determination of lamivudine and stavudine in tablet dosage form is developed and validated. The chromatographic analysis was performed on a C 18column grace smart RP18 (250×4.6 mm, 5 μm) in isocratic mode, the mobile phase consisted of methanol, acetonitrile and 0.05 M phosphate buffer (adjusted topH 4.5 with ortho-phosphoric acid) at a ratio of 60:20:20 v/v/v, and a flow rate of 1.0 mL/min and ASPD detector is used. The eluents were monitored at 254 nm. The retention time of lamivudine and stavudine were found to be 2.50 min and 4.25 min, respectively. The linear ranges were found to be 10-602 2 μg/mL (r =0.9992) for lamivudine and 10-60 μg/mL (r =0.999) for stavudine . The proposed method is also found to be accurate, precise androbust. The method could be applied to routine quality control of pharmaceutical formulations containing lamivudine and stavudine.