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Development and validation of HPTLC method for simultaneous estimation of cinitapride and omeprazole in combined dosage form | Abstract
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Abstract

Development and validation of HPTLC method for simultaneous estimation of cinitapride and omeprazole in combined dosage form

Author(s): Hitesh J. Vekaria, Makani Yogesh, Kinesh Patel

A simple, precise, specific and accurate high performance thin layer chromatographic method has been developed for the simultaneous determination of Cinitapride (CNT) and Omeprazole (OMZ) in pharmaceutical dosage form. The separation was carried out on Merck HPTLC aluminum plates of silica gel G60 F254, (20 × 10 cm) with 250 μm thickness using chloroform : ethyl acetate: methanol (7.3: 2: 0.7, v/v/v) as mobile phase. HPTLC separation of the two drugs followed by densitometric measurement was carried out in the absorbance mode at 277 nm. The drugs were resolved satisfactorily with Rf values of 0.46 ± 0.01 and 0.68 ± 0.01 for CNT and OMZ, respectively. The linear regression analysis data for the calibration plots showed good linear relationship with R2=0.999 and 0.999 for CNT and OMZ, respectively in the concentration range of 30-180 ng/spot for CNT and 200-1200 ng/spot for OMZ. The method was validated for accuracy, precision, specificity and robustness. The limit of detection and quantitation were 2.79 and 8.46 ng/spot, respectively for CNT and 18.22 and 55.1 ng/spot, respectively for OMZ. The proposed developed HPTLC method can be applied for identification and quantitative determination of OMZ and CNT in bulk drug and drug formulation.