METHOD DEVELOPMENT AND VALIDATION OF LAMIVUDINE AND TINOFOVIR DISOPROXIL FUMERATE HPLC IN PHARMACEUTICAL DOSAGE FORM

A simple, linear, precise and accurate Reverse phase high Performance Liquid Chromatographic method was developed and validated for the analysis of Lamivudine and Tinofovir disproxil fumerate. The chromatographic e Inertsil ODS C18, 5μ , 150 mm x 4.6 mm] utilizing a mobile phosphoric acid buffer and methanol in the ratio of 30:70 at a flow rate of 0.6 ml/min with UV e was found to be 2.147 and 3.494min respectively. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation. The method was accurate with a mean recovery of 99.15%, 99.30% for inofovir disproxil fumerate respectively. The percentage RSD for Lamivudine is 0.17 and for Tinofovir disproxil fumerate is 0.14. Method was linear with a correlation coefficient of 0.999 for both ned was 2.97, 9.96 and 2.98, 9.98 for Lamivudine and Tinofovir disproxil fumerate respectively. The developed method was validated in terms of robustness by changing flow rate and organic composition in mobile phase. The results obtained were measured in terms of system suitability which were within limits indicating that the method is robust. Lamivudine, Tinofovir disproxil fumerate, RP - HPLC, Validation, UV