Development and validation of first order derivative spectrophotometric method for simultaneous estimation of Omeprazole and Cinitapride in pharmaceutical dosage form

作者: Raj, H. A. ; Makani, Y. G.

The use of 1st order derivative spectrophotometry allowed simultaneous estimation of Omeprazole and Cinitapride, at their resp. zero crossing point (ZCP) in fixed dose combination products.The absorbance values at 263.2 nm (ZCP of cinitapride) and 253.8 nm (ZCP of omeprazole) of 1st derivative spectrum were used for the estimation of Omeprazole and Cinitapride resp. without mutual interference in MeOH.The method was found to be linear (r2>0.9995) in the range of 7-42 μg/mL for Omeprazole.The linear correlation was obtained (r2>0.9992) in the concentration range of 1-6 μg/mL for Cinitapride.The method was validated for as per ICH Q2 (R1) guidelines.The limit of determination was 0.06μg/mL and 0.33μg/mL for Omeprazole and Cinitapride, resp.The limit of quantification was 0.18μg/mL and 1.00μg/mL for Omeprazole and Cinitapride, resp.The proposed method is simple, rapid, precise, and accurate and hence can be successfully applied for the simultaneous determination of Omeprazole and Cinitapride in formulations.

International Research Journal of Pharmacy

Development and validation of a RP-HPLC method for simultaneous estimation of Omeprazole and Cinitapride in bulk and capsule dosage form

作者: Nagesh, P. ; Ratna Prasanna, N. ; Nagarajan, G. ; Triveni, C. ; Ramana, B. V.

A simple reversed-phase high-performance liquid chromatog. (RP-HPLC) method was developed and validated for simultaneous determination of Omeprazole and Cinitapride in bulk and Capsule dosage form.Chromatog. anal. was performed on a Symmetry C8 column (150 × 4.5 mm, 5μm) column ambient temperature with a mixture of mixed phosphate buffer and Acetonitrile in the ratio 50:50 (mixed phosphate buffer preparation; 1.625 gm of potassium Dihydrogen phosphate and 0.3 gm of Di potassium hydrogen phosphate in 550 mL HPLC grade water, pH = 6.0 adjust with phosphoric acid) as mobile phase, at a flow rate of 1.0 mL min^-1.UV detection was performed at 287 nm.The method was validated for accuracy, precision, specificity, linearity, and sensitivity.The retention times of Omeprazole and Cinitapride were 2.49 and 3.650 min, resp.Calibration plots were linear over the concentration ranges 5-30 μg mL^-1 and 0.75-4.5 μg mL^-1 for Omeprazole and Cinitapride, resp.The Limit of detection was 1.43570 and 0.086 μg mL^-1 and the quantification limit was 4.35 μg mL^-1 and 0.26 μg mL^-1 for Omeprazole and Cinitapride, resp.The accuracy of the proposed method was determined by recovery studies and found to be 98.62% to 100.37%.Com. capsule formulation was successfully analyzed using the developed method and the proposed method is applicable to routine anal. of determination of Omeprazole and Cinitapride in bulk and capsule dosage form.

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适应症	国家/地区	公司	日期
消化不良	印度	Zydus Cadila Healthcare Ltd.	2010-01-01
胃食管反流	印度	Zydus Cadila Healthcare Ltd.	2010-01-01
胃溃疡	印度	Zydus Cadila Healthcare Ltd.	2010-01-01