Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF, TENOFOVIR DISOPROXIL FUMARATE AND LAMIVUDINE IN COMBINED TABLET DOSAGE FORM BY RP-HPLC

B. Divya* and B. Thangabalan

ABSTRACT

A simple, rapid reverse - phase high performance liquid 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 estimation was carried out on a Chromosil C18 (250 mm x 4.6mm i.d., particle size 5μm) column with a mixture of acetonitrile: methanol: water in the ratio of 30:50:20 (v/v) as mobile phase. UV detection was performed at 261 nm. The method was validated for linearity, accuracy, precision, specificity and sensitivity as per ICH guidelines. The developed and validated method was successfully used for the quantitative analysis of commercially available tablet dosage form. The retention time was 2.17 and 3.84 min for Lamivudine and Tenofovir disoproxil fumarate, respectively. The flow rate was 1.0 mL/min. The calibration curve was linear over the concentration range of 10-250 μg/mL for both Lamivudine and Tenofovir disoproxil fumarate. The LOD and LOQ values were found to be 0.5304 and 1.6072 μg/ml for Lamivudine and 0.5979 and 1.1812 μg/ml for Tenofovir disoproxil fumarate, respectively. The high percentage of recovery and low coefficient of variance confirm the suitability of the method for the simultaneous estimation of Lamivudine and Tenofovir disoproxil fumarate in pure and in tablet dosage form.

Keywords: Lamivudine; Tenofovir disoproxil fumarate; RP-HPLC; Validation.