High-Performance Thin-Layer Chromatography Method for the Simultaneous Determination of Itopride, Pantoprazole, and Mosapride in Their Formulations and Spiked Human Plasma

The combination of itopride (ITP), pantoprazole (PAN), and mosapride (MS) is widely used in the treatment of many gastrointestinal tract (GIT) disorders. For that purpose, a new, simple, precise, accurate, and rapid high-performance thin-layer chromatography (HPTLC) method was developed and validated for the simultaneous determination of ITP, PAN, and MS in their pharmaceutical formulations. The method used Merck HPTLC aluminum plates precoated with silica gel 60 F-254 as the stationary phase. The mobile phase consisted of methylene chloride. ethyl acetate. methanol. ammonia (25%) (12: 2: 0.8: 0.2, v/v); this system was found to give compact spot of itopride (R-f value of 0.22 +/- 0.008), pantoprazole (R-f value of 0.41 +/- 0.006), and mosapride (R-f value of 0.62 +/- 0.029). The wavelength of thin-layer chromatography (TLC) scanner was set at 289 nm for both detection and quantitation. The calibration curves were linear over the range of 100-1500 ng spot(-1) for ITP and MS, and 70-1500 ng spot(-1) for PAN. The detection limits were 32.5, 16.8, and 29.8 for ITP, PAN, and MS, and the quantitation limits were 98.5, 50.3, and 90.5 for ITP, PAN, and MS. The proposed analytical method was validated according to the International Conference on Harmonization (ICH) guidelines, and the results were acceptable. The proposed method has been successfully applied for the determination of the studied drugs in their pharmaceutical preparations as well as in spiked human plasma and it gave excellent percent of recovery. The results showed excellent agreement with the reported method with respect to precision and accuracy.