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Analytical method development and validation for simultaneous estimation of cinitapride and pantoprazole in pharmaceutical dosage form

机译:同时估算药物剂型中的西那必利和pan托拉唑的分析方法开发和验证

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A new, simple, precise, accurate, rapid as well as cost effective reverse phase HPLC method was developed for simultaneous estimation of cinitapride and pantoprazole in pharmaceutical dosage form. Chromatographic separation achieved isocratically on a C18 column by utilizing mobile phase Methanol: Water: Triethylamine (90: 10: 0.2v/v/v) at the flow rate of 1ml/min with UV detection at 277nm. The retention time of cinitpride and pantoprazole are 4.80min and 2.40min respectively. The method is accurate (99.2-102.9%), and linear within range 3-15μg/ml and 4-20μg/ml for ciitapride and pantoprazole respectively. The correlation coefficient was found to be r2= 0.999 and 0.997 for CNP and PNP respectively. The LOD for cinitapride and pantoprazole 0.223μg/ml and 0.498μg/ml respectively and LOQ are 0.675μg/ml and 1.509μg/ml respectively. The proposed method is applicable for routine analysis of simultaneous estimation of cinitapride and pantoprazole in combine pharmaceutical dosage form.
机译:开发了一种新的,简单的,精确的,准确的,快速且具有成本效益的反相HPLC方法,用于同时估算药物剂型中的西尼他必利和pan托拉唑。通过使用流动相甲醇:水:三乙胺(90:10:0.2v / v / v)以1ml / min的流速在C18色谱柱上等度色谱分离,并在277nm处进行UV检测。 Cinitpride和Pantoprazole的保留时间分别为4.80min和2.40min。该方法准确度高(99.2-102.9%),在西酞普利和μ托拉唑分别在3-15μg/ ml和4-20μg/ ml范围内呈线性。发现CNP和PNP的相关系数分别为r2 = 0.999和0.997。西尼他必利和pan托拉唑的LOD分别为0.223μg/ ml和0.498μg/ ml,LOQ分别为0.675μg/ ml和1.509μg/ ml。该方法可用于常规分析同时测定联合药物剂型中的西尼特必利和pan托拉唑。

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