Quantitative planar chromatographic analysis of pantoprazole sodium sesquihydrate and domperidone in tablets

Abstract

A simple, rapid, and reliable HPTLC method has been established and validated for determination of pantoprazole sodium sesquihydrate and domperidone in tablets. Identification and determination were performed on 10 cm × 20 cm aluminum-backed HPTLC plates coated with 0.2 mm layers of silica gel 60 F 254 , previously washed with methanol. Methanol-water-ammonium acetate, 4 + 1 + 0.5 ( v / v ), was used as mobile phase. The spots were scanned at λ = 286 nm. Calibration plots were established showing the dependence of response (peak area) on the amount chromatographed. The validated calibration ranges were 2000–10,000 ng per spot ( r = 0.999) and 500–2500 ng ( r = 0.999) for pantoprazole sodium sesquihydrate and domperidone, respectively. The suitability of this HPTLC method for quantitative determination of these compounds was proved by validation in accordance with ICH Guidelines. The method was used for determination of the compounds in commercial pharmaceutical dosage forms. The method is simple, reproducible, and accurate and is more economic than other chromatographic techniques used for routine quality control.