Rapid quantitative determination of zidovudine, lamivudine and nevirapine drugs in pharmaceutical tablets by stability-indicating monolithic liquid chromatography: validation, greenness, blueness and whiteness studies.

New ecological, sustainability and practicality analytical methodologies became constant in the modern pharmaceutical analysis. Likewise, a simple, rapid, stability-indicating high-performance liquid chromatography (HPLC) method was developed and validated for simultaneous determination of lamivudine (3TC), zidovudine (ZDV) and nevirapine (NVP) in pharmaceutical formulations. The HPLC method was carried out on a monolithic C18 column (100 mm × 4.6 mm i.d.), maintained at 30°C. The mobile-phase consisted of ammonium acetate (pH 4.5; 10 mM)-methanol-acetonitrile (65:28:7, v/v/v), run at a flow rate of 2.0 mL/min, using photodiode array (PDA) detection at 270 nm. Validation parameters such as the specificity, linearity, precision, accuracy and robustness were evaluated according to the International Council for Harmonisation (ICH) guidelines. From the results obtained, the developed HPLC method was successfully applied for the simultaneous quantitative analysis of 3TC, ZDV and NVP in tablet dosage forms. The chromatographic separation was obtained in less than 3 min and it was suitable for high-throughput analysis. In addition, the greenness assessment, the holistic overall evaluation and the practicality check using the novel Analytical GREEnness Metric Approach and Software (AGREE) calculator, the RGB-12 model and Blue Applicability Grade Index (BAGI), respectively, were performed. The results demonstrated the environmental friendliness (AGREE), practicality (BAGI) and holistic sustainability profile (RGB-12 model) of the proposed method.