Development and validation of new analytical method for the simultaneous estimation of omeprazole and domperidone in pharmaceutical dosage form by UV spectrophotometry

International Journal of Research In Pharmaceutical Chemistry and Analysis Pub Date : 2019-04-15 DOI:10.33974/ijrpca.v1i2.63

V. P. Kumar, C. Chandra, N. Devendra, M. K. Kumar, S. R. Basha, C. S. Kumar, B. S. Naidu

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Abstract

A simple, rapid and precise method was developed for the quantitative simultaneous determination of Omeprazole and Domperidone in combined pharmaceutical-dosage forms. The method was based on UV-Spectrophotometric determination of two drugs, using simultaneous equation method. It involves absorbance measurement at 291 nm (λmax of Omeprazole) and 289 nm (λmax of Domperidone) in Methanol: Acetonitrile (30:70 v/v). For UV Spectrophotometric method, linearity was obtained in concentration range of 1-15 µg/ml for Domperidone and 1-50 µg/ml for Omeprazole respectively, with regression 0.999 and 0.999 for Domperidone and Omeprazole respectively. Recovery was in the range of 99 -103%; the value of standard deviation and %R.S.D were found to be < 2 %; shows the high precision of the method., in accordance with ICH guidelines. The method has been successively applied to pharmaceutical formulation and was validated according to ICH guidelines.

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紫外分光光度法同时测定药品剂型中奥美拉唑和多潘立酮含量的新方法的建立与验证

建立了一种简便、快速、准确的同时定量测定复方奥美拉唑和多潘立酮含量的方法。本方法以紫外分光光度法测定两种药物为基础，采用联立方程法。在甲醇:乙腈(30:70 v/v)中，在291 nm(奥美拉唑的λmax)和289 nm(多潘立酮的λmax)处进行吸光度测量。紫外分光光度法在多潘立酮1 ~ 15µg/ml、奥美拉唑1 ~ 50µg/ml浓度范围内线性良好，多潘立酮和奥美拉唑的回归分别为0.999和0.999。回收率为99 ~ 103%;标准偏差和% rs的值D < 2%;表明该方法具有较高的精度。，符合ICH指南。该方法已先后应用于药物制剂，并根据ICH指南进行了验证。

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International Journal of Research In Pharmaceutical Chemistry and Analysis

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