Development Of Analytical Methods and Validation of Tenofovir, Lamivudine and Efavirenz by Rp-HPLC Method

Abstract

The aim of this research work was develop simple, precise and rapid RP-HPLC Method of analysis of Tenofovir,Lamivudine and Efavirenz in bulk and pharmaceutical dosage form.

            RP-HPLC method was developed for the estimation of Tenofovir,Lamivudine and Efavirenz in tablet dosage form with the help of HPLC approaches. The proposed methods were applied for the determination of drug in tablet dosage form. A rapid and reliable RP-HPLC method was developed and validated estimation of Tenofovir,Lamivudine and Efavirenz, in tablet dosage form. The RP-HPLC method was performed C18-(100mm x 4.6 mm,) 2.5 & C18-(250mm x 4.6 mm,) 5.0 μm particle size in gradient mode, and the sample was analysed using methanol and pH buffer (0.05% OPA with TEA) as a mobile phase for Tenofovir, Lamivudine and Efavirenz 70:30ml, 0.7 ml flow by the retention time for Tenofovir, Lamivudine and Efavirenz found 1.808,2.93 and 7.53 min respectively. The method was applied to marketed tablet formulations. The tablet assay was performed for combination was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH guidelines. Validation related the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots by HPLC were linear over 5-25 and 10-50 μg/ml for Tenofovir, Lamivudine and Efavirenz The method can be used for routine of the quality control in pharmaceuticals.

           The RP-HPLC method was found to be simple, economical and rapid as compared to MS method was found to be more accurate, precise and robust. Both these methods can be used for routine analysis of TENO,LAMI and EFA in tablet dosage form.