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

Abstract

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 tenofovirdisoproxil-fumarate in tablet formulations was developed. Lamivudine/tenofovirdisoproxil-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-disoproxilfumarate, 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. K E Y W O R D S

Simultaneous UV-spectrophotometric determination of tertiary components in FDC of lamivudine, tenofovir disoproxil fumarate, and efavirenz in solid dose formulation

“…The regression line had the best fitting using a second-order polynomial equation for each of the APIs with r2 ≥ 0.98 at concentrations ranging from 375-900 ng/spot for 3TC, TDF, and 750-1800 ng/spot for EFV, respectively, with a satisfactory level of accuracy, mean recoveries in the range of 98 to 103%, and a high degree of selectivity for the APIs [39] . Several other methods for simultaneous qualitative measurement of pharmaceutical goods have been proposed [40,41] . The study's purpose was to develop a simple, accurate, precise, fast, cost-effective, and reproducible UV spectrophotometric method for measuring LAM, TDF, and EFV, as well as bulk and pharmaceutical formulations, using commonly available materials, reagents, and equipment.…”

Comparative study of UV spectroscopy, RP-HPLC and HPTLC methods for quantification of antiviral drug lamivudine in tablet formulation

“…An extensive literature survey disclosed that LMU has been determined independently or in combination with other drugs by UV spectroscopy [4,5], RP-HPLC [6][7][8][9][10][11][12][13] and HPTLC [14][15][16]; however, there was not a single research work that has been done reporting that LMU individually was determined simultaneously by all three methods, i.e., UV spectrophotometry, RP-HPLC and HPTLC, and investigating the best method among them. Further to carry out stability indicating study of the selected superior method for separating the active analyte present in the pharmaceutical dosage is carried out, which makes the present research work unique and novel.…”

Box–Behnken design aided optimization and validation of developed reverse phase HPLC analytical method for simultaneous quantification of dolutegravir sodium and lamivudine co‐loaded in nano‐liposomes

“…Diverse procedures are reported for the quantitation of LAM and DTG individually and in combination with other antiretroviral drugs in the literature [13]. These reports mainly include techniques such as HPLC‐MS/MS and UPLC‐MS /MS [14–16].…”