RP-HPLC DEVELOPMENT AND VALIDATION OF ASSAY AND UNIFORMITY OF DOSAGE UNITS BY CONTENT UNIFORMITY FOR IN HOUSE LAMIVUDINE AND ABACAVIR COMBINED TABLET
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2013, Vol 1, Issue 5
Abstract
A precise, accurate, highly sensitive, rugged and robust HPLC method has been developed and validated for the assay and content uniformity of Lamivudine and Abacavir in combined tablets. The method was developed using pH 3.0 Phosphate buffer: Methanol (80:20 v/v) in isocratic mode and Waters Symmetry C 18 (100 X 4.6mm), 3.5µ column. Flow rate and detection wavelengths were fixed at 0.5 ml/min and 276 nm. Retention times for Lamivudine and Abacavir were found to be 2.122 and 3.194 minutes respectively. Both methods were validated as per ICH guidelines to test their suitability for intended purpose. Linearity ranges for Lamivudine and Abacavir were set at 50-150 µg/ml with correlation coefficient 1.000 and 100-300 µg/ml with correlation coefficient 1.000. Accuracy values for both methods were found to be found to be 100.09-100.14% for Lamivudine and 99.99-100.11 for Abacavir. Methods found to be robust against changes in flow rate, organic composition, pH of mobile phase and detection wavelength. The proposed method is suitable for quality control analysis of in house Lamivudine and Abacavir combined tablets.
Authors and Affiliations
K. Ranjith, M. V. Basaveswara Rao, T. E. G. K. Murthy
Keywords
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