Simple thin layer chromatography–ultraviolet spectrophotometric method for quality assessment of binary fixed‐dose‐combinations of lamivudine/tenofovir disoproxil fumarate and lamivudine/zidovudine in tablet formulations.

Antiretroviral fixed‐dose‐combination drugs are best assayed with high‐performance liquid chromatography, or liquid chromatography–tandem mass spectrometry. However, most scientists in developing nations have no access to these expensive instruments. A more affordable quantitative technique is the use of ultraviolet–visible spectroscopy—where often the absorption spectra of these antiretrovirals are overlapping; thus complex derivative methodologies are required for quantification. A simple, rapid, and accurate thin layer chromatography–ultraviolet spectrophotometric method for the quantification of binary mixtures of lamivudine, zidovudine, and tenofovir–disoproxil–fumarate in tablet formulations was developed. Lamivudine/tenofovir–disoproxil–fumarate and lamivudine/zidovudine were extracted and separated on glass thin‐layer chromatography plates. Drugs were identified in ultraviolet light at 254 nm and quantified in acidic medium using ultraviolet spectrophotometry. The retardation factors were 0.43, 0.79, and 0.81 for lamivudine, tenofovir–disoproxil–fumarate, and zidovudine, respectively, with corresponding absorption maxima at 270, 260, and 265 nm. Linearity ranged from 1 to 40 µg/mL for all drugs (R = 0.9998–0.9999), while recovery studies were 95.10–102.11% and amount in formulations ranged from 97.99 ± 0.63 to 101.47 ± 2.39%. The paired t‐test (n = 5) indicated no significant difference between the proposed and high‐performance liquid chromatography methods, hence comparable and can be used as an alternative method in routine quality determination of antiretroviral medicines. [ABSTRACT FROM AUTHOR]