RP-HPLC Assay Method Validation for the estimation of new Anti-retroviral drug Lamivudine in Bulk and Tablet dosage form
Journal Title: International Journal of Pharmacy and Analytical Research - Year 2012, Vol 1, Issue 1
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. Key words: RP-HPLC, Lamivudine, Pharmaceutical dosage form.
Authors and Affiliations
Venkatesh M
Keywords
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