Stability-Indicating Chromatographic Methods for Simultaneous Determination of Mosapride and Pantoprazole in Pharmaceutical Dosage Form and Plasma Samples

Abstract

Simple, sensitive, selective, precise, and stability-indicating thin-layer chromatography (TLC) and high-performance liquid chromatography (HPLC) methods for the determination of mosapride and pantoprazole in pharmaceutical tablets were developed and validated as per the International Conference on Harmonization guidelines. The TLC method employs aluminum TLC plates precoated with silica gel 60F 254 as the stationary phase and ethyl acetate/methanol/toluene (4:1:2, v/v/v) as the mobile phase to give compact spots for mosapride (R f 0.73) and pantoprazole (R f 0.45) separated from their degradation products; the chromatogram was scanned at 276 nm. The HPLC method utilizes a C18 column and a mobile phase consisting of acetonitrile/methanol/20 mM ammonium acetate (4:2:4, v/v/v) at a flow rate of 1.0 mL min -1 for the separation of mosapride (t R 11.4) and pantoprazole (t R 4.4) from their degradation products. Quantitation was achieved with UV detection at 280 nm. The same HPLC method was successfully used in performing calibrations in lower concentration ranges for both drugs in human plasma using ezetimibe as internal standard. The methods were validated in terms of accuracy, precision, linearity, limits of detection, and limits of quantification. Mosapride and pantoprazole were exposed to acid hydrolysis and then analyzed by the proposed methods. As the methods could effectively separate the drugs from their degradation products, these techniques can be employed as stability-indicating methods that have been successively applied to pharmaceutical formulations without interference from the excipients. Moreover the HPLC method was successfully used in the determination of both drugs in spiked human plasma.

Enhanced spectrofluorimetric determination of esomeprazole and pantoprazole in dosage forms and spiked human plasma using organized media

“…Reviewing the literature revealed that few analytical methods have been developed for the EMZ assay, including highperformance liquid chromatography (HPLC) (4-7) and liquid chromatography mass spectrometry (8)(9)(10). On the other hand, numerous methods have been reported for the determination of PRZ, such as spectrophotometry (11)(12)(13)(14)(15), high-performance thinlayer liquid chromatography (16)(17)(18), capillary electrophoresis (19,20), voltammetry (21,22), flow injection analysis (23), HPLC (4,(24)(25)(26)(27)(28) and liquid chromatography mass spectrometry (29,30).…”

Instrumental analysis of some anti-ulcer drugs in different matrices

“…Quantitation was achieved with UV detection at 280 nm. [97] Furthermore, a reversed phase liquid chromatographic method was developed for the determination of cinitapride and pantoprazole sodium in their marketed formulation. A reversed phase C 18 column with mobile phase consisting of acetonitrile: water: triethylamine (80: 20: 0.05, v/v/v) were used.…”