RP-HPLC Assay Method Validation for the estimation of new Anti- retroviral drug Lamivudine in Bulk and Tablet dosage form

Abstract

A Reverse phase HPLC method was developed for estimation of the Lamivudine in bulk and tablet formulation by using ODS column  (250mm×4.6mm,  5µm) and Acetate  buffer:  acetonitrile  (50:50)  as mobile  phase,  at a flow rate of 1.5ml/min.  The detection was carried at the 272nm the retention time of the Lamivudine  is 1.850. The  developed  method  was  validated  for  the  various  parameters  as  per  the  ICH  guidelines  like  accuracy precision,  linearity  and range,  Robustnes.    Linearity  was obtained  in the concentration  range  of 10µg/ml  to 50µg/ml with correlation coefficient  of 0.999. The accuracy of the method was assessed by recovery studies at three different concentration  levels. The percentage  recovery of Lamivudine  was found to be in the range of 98% -102%. The method was found to be precise as indicated by the repeatability, inter-day, intra-day analysis, showing %RSD less than 2.