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Three different methods for determination of binary mixture of Amlodipine and Atorvastatin using dual wavelength spectrophotometry

机译:双波长分光光度法测定氨氯地平和阿托伐他汀二元混合物的三种不同方法

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摘要

Three simple, specific, accurate and precise spectrophotometric methods depending on the proper selection of two wavelengths are developed for the simultaneous determination of Amlodipine besylate (AML) and Atorvastatin calcium (ATV) in tablet dosage forms. The first method is the new Ratio Difference method, the second method is the Bivariate method and the third one is the Absorbance Ratio method. The calibration curve is linear over the concentration range of 4-40 and 8-32 μg/mL for AML and ATV, respectively. These methods are tested by analyzing synthetic mixtures of the above drugs and they are applied to commercial pharmaceutical preparation of the subjected drugs. Methods are validated according to the ICH guidelines and accuracy, precision, repeatability and robustness are found to be within the acceptable limit. The mathematical explanation of the procedures is illustrated.
机译:根据两种波长的正确选择,开发了三种简单,特异性,准确和精确的分光光度法,用于同时测定片剂剂型中的苯磺酸氨氯地平(AML)和阿托伐他汀钙(ATV)。第一种方法是新的“比率差”方法,第二种方法是“双变量”方法,第三种方法是“吸收率”方法。 AML和ATV的浓度曲线分别在4-40和8-32μg/ mL的浓度范围内呈线性关系。通过分析上述药物的合成混合物来测试这些方法,并将其应用于所治疗药物的商业药物制备。根据ICH指南对方法进行了验证,发现准确性,精密度,可重复性和鲁棒性均在可接受的范围内。说明了该过程的数学解释。

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