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A Validated RP-HPLC Method for Simultaneous Estimation of Atenolol and Indapamide in Pharmaceutical Formulations

机译:一种经过验证的RP-HPLC方法,用于同时估计Atenolol和Indapamide在药物制剂中的

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摘要

A simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of atenolol and indapamide from bulk and formulations. Chromatographic separation was achieved isocratically on a Waters C18 column (250×4.6 mm, 5 µ particle size) using a mobile phase, methanol and water (adjusted to pH 2.7 with 1% orthophosphoric acid) in the ratio of 80:20. The flow rate was 1 mL/min and effluent was detected at 230 nm. The retention time of atenolol and indapamide were 1.766 min and 3.407 min. respectively. Linearity was observed in the concentration range of 12.5-150 µg/mL for atenolol and 0.625-7.5 µg/mL for indapamide. Percent recoveries obtained for both the drugs were 99.74-100.06% and 98.65-99.98% respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method developed can be used for the routine analysis of atenolol and indapamide from their combined dosage form.
机译:开发了一种简单,快速,精确,选择性和准确的RP-HPLC方法,并验证了同时测定阿谷醇和吲达咪唑免受散装和制剂。使用流动相,甲醇和水(用1%正向磷酸调节至pH2.7)的比例,在80:20的比例下,在水中的C18柱(250×4.6mm,5μm,5μm,5μm)上进行色谱分离。流速为1ml / min,在230nm下检测流出物。阿绿龙和吲普酰胺的保留时间为1.766分钟和3.407分钟。分别。在吲达纳米洛尔的12.5-150μg/ ml的浓度范围内观察到线性度和0.625-7.5μg/ ml。对药物获得的百分比分别为99.74-100.06%和98.65-99.98%。该方法根据ICH指南验证,关于特异性,线性,准确性,精度和稳健性。开发的方法可用于从其组合剂型的阿托尔罗尔和吲达咪唑的常规分析。

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