Development and Validation for the Simultaneous Estimation of Lamivudine and Tenofovir Disoproxil Fumarate by RP-HPLC Method

Abstract

A simple, rapid reverse phase high performance chromatographic method has
been developed and validated for the simultaneous estimation of Lamivudine
and Tenofovir disoproxil fumarate in pure and in tablet dosage form. The
chromatographic separation of Lamivudine and Tenofovir was achieved on
symmetry column C18 4.6 x 150mm, 5 µm, Make: Ace with a mixture of
methanol and water pH adjusted with 3.2 in the ratio of 70:30 v/v as mobile
phase at a flow rate of 0.8 mL/ min and elutes was monitored at 260 nm. The
method was validated for linearity, accuracy, precision, robustness and
ruggedness as per ICH guidelines. The retention time for Lamivudine and
Tenofovir disoproxil fumarate were found to be 2.45 and 3.99 respectively.
Recovery of Lamivudine and Tenofovir disoproxil fumarate were found to be
the range of 100.12 % and 99.53 % and linearity in the range of 25-125 µg/ml.
The proposed method was rapid, economical and suitable for routine control
quality analysis