ABSTRACT:
This paper describes a new, simple, precise, and accurate HPTLC method for simultaneous estimation of cinitapride and pantoprazole in pharmaceutical dosage form. Chromatographic separation of the drugs was performed on aluminium plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of ethyl acetate: methanol 9: 1(v/v). Densitometric evaluation of the separated zones was performed at 278 nm. The two drugs were satisfactorily resolved with Rf values 0.43±0.00 and 0.62±0.01 for cinitapride and pantoprazole respectively. The accuracy and reliability of the method was assessed by evaluation of linearity 100-700 ng/spot for cinitapride and 1000-7000 ng/spot for pantoprazole, precision (intra-day RSD 0.05–0.40 % and inter-day RSD 0.13–0.39 % for cinitapride, and intra-day RSD 0.10–0.20 % and inter-day RSD 0.13–0.60 % for pantoprazole), accuracy (98.6 - 100.4 % for cinitapride and 98.2 – 101.5% for pantoprazole), and specificity (100.40 ± 1.01% for cinitapride and 99.19 ± 0.99% for pantoprazole), in accordance with ICH guidelines. This method was successfully applied to the determination of these drugs in pharmaceutical dosage forms.