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A Simple and Sensitive HPTLC Method for Quantitative Analysis of Darunavir Ethanolate Tablets

A quantitative high-performance thin-layer chromatography (HPTLC) method for determination of darunavir ethanolate (DRV) in tablets has been established and validated. DRV from the formulations was separated and identified on silica gel 60 F254 HPTLC plates with toluene-ethyl acetate-methanol 7.0:2.0:1.0 (v/v) as mobile phase. The plates were developed to a distance of 8 cm. Quantification was performed at λ = 267 nm. Well-resolved bands were obtained for DRV. The method was validated for specificity, precision, robustness, and accuracy. The calibration plot for DRV standard was linear in the range 250–1750 ng per band with r = 0.9994, slope = 0.4253, and intercept = 44.81. The limits of detection and quantification were 15.28 and 45.84 ng per band, respectively. The method is selective, sensitive, and specific, with potential application in pharmaceutical analysis.