A Validated High-Performance Thin-Layer Chromatographic Method for the Assay of Two Binary Mixtures Containing Omeprazole or Its Isomer Esomeprazole in Pharmaceutical Dosage Forms

A simple validated high-performance thin-layer chromatographic (HPTLC) method was developed for the determination of two binary mixtures containing omeprazole with ketoprofen (mixture 1) and esomeprazole with naproxen (mixture 2). The separation was carried out on Merck HPTLC aluminum plates precoated with silica gel 60 F-254 (20 x 10 cm) with 250-mu m thickness using chloroform-ethyl acetate (3:7, v/v) as the mobile phase. HPTLC separation of the four drugs in the two binary mixtures, followed by densitometric measurement, was carried out in the absorbance mode at 302 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r > 0.999 in the concentration ranges of 0.03-0.3 mu g band(-1) for omeprazole (OME) and esomeprazole (ESO), 0.2-2 mu g band(-1) for ketoprofen (KETO), and 0.5-6 mu g band(-1) for naproxen (NAP). The proposed method was validated and successfully applied for the analysis of pharmaceutical formulations and synthetic mixtures containing the two combinations. The method was validated and showed good performances in terms of linearity, range, limits of detection and quantitation, accuracy, precision, specificity, and robustness.