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Development and validation of an RP-HPLC method for the simultaneous determination of Escitalopram Oxalate and Clonazepam in bulk and its pharmaceutical formulations

机译:同时测定散装的依草普仑草酸盐和氯硝西am及其药物制剂的RP-HPLC方法的开发和验证

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A Simple, efficient and reproducible reverse phase high performance liquid chromatographic method was developed and validated for the Simultaneous determination of Escitalopram oxalate and Clonazepam in combined dosage form. The separation was effected on a Hypersil ODS C18 column (250mm X 4.6mm; 5μ) using a mobile phase mixture of buffer and acetonitrile in a ratio of 50:50 v/v at a flow rate of 1.0ml/min. The detection was made at 240nm. The retention time of Escitalopram oxalate and Clonazepam was found to be 2.840± 0.007min and 4.007±0.006 min. Calibration curve was linear over the concentration range of 20-120μg/ml and 1-6μg/ml for Escitalopram oxalate and Clonazepam. All the analytical validation parameters were determined and found in the limit as per ICH guidelines, which indicates the validity of the method. The developed method is also found to be precise, accurate, specific, robust and rapid for the simultaneous determination of Escitalopram oxalate and Clonazepam in tablet dosage forms.DOI:?http://dx.doi.org/10.3329/icpj.v1i8.11249 International Current Pharmaceutical Journal 2012, 1(8): 193-198
机译:开发了一种简单,高效且可重现的反相高效液相色谱方法,并验证了联合剂型中草酸艾司西酞普兰和氯硝西am的同时测定。使用缓冲液和乙腈的流动相混合物,以50:50 v / v的比例,以1.0ml / min的流速在Hypersil ODS C18色谱柱(250mm X 4.6mm;5μ)上进行分离。在240nm处进行检测。草酸依西酞普兰和氯硝西am的保留时间分别为2.840±0.007min和4.007±0.006min。草酸依西酞普兰和氯硝西p的浓度范围在20-120μg/ ml和1-6μg/ ml范围内是线性的。根据ICH指南确定了所有分析验证参数并在极限值内发现,这表明该方法的有效性。还发现了所开发的方法准确,准确,专一,稳定,快速,可同时测定片剂剂型中的草酸依西酞普兰和氯硝西am.DOI:?http://dx.doi.org/10.3329/icpj.v1i8。 11249国际最新药学杂志2012,1(8):193-198

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