Development of high performance thin layer chromatography for simultaneous analysis of lamivudine and tenofovir disoproxil fumarate

Abstract

Background: The quality of antiretroviral medicines (ARVs) is vital in the management of HIV infection. Nevertheless, the effort for the management of HIV infection is impeded by the increasing problem of counterfeit ARVs.

Objectives: The aim of this study was to avail a less expensive, accurate, and precise analytical method for the simultaneous determination of lamivudine and tenofovir disoproxil fumarate in fixed dosage combination.

Methods: During the method development and validation, a high performance thin layer chromatography (HPTLC) system with WinCATS software was used. Freshly prepared solutions in methanol were spotted on HPTLC silica gel 60F₂₅₄ plates. The mobile phase was composed by 20 mL of toluene and 10 mL of methanol, both analytical grades.

Results: The retention factor (Rf) was from 0.35 to 0.38 and from 0.57 to 0.59, respectively for lamivudine and tenofovir disoproxil fumarate. The coefficients of variation (CV) for repeatability were 1.3% and 3.4%, respectively for tenofovir disoproxil fumarate and lamivudine. The CVs for intermediate precision were 3.9% and 3.8%, respectively for lamivudine and tenofovir disoproxil fumarate. The analytical range was 2.000-3.100 μg for both lamivudine and tenofovir disoproxil fumarate.

Conclusions: This method is recommended in routine analysis of pharmaceutical products containing lamivudine and tenofovir disoproxil fumarate.

Keywords: HPTLC, Lamivudine, Tenofovir disoproxil fumarate