苯磺酸氨氯地平散装和片剂的紫外分光光度法研究与验证

P. Priya, Archana Gahtori
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引用次数: 1

摘要

分析方法的开发和验证是药物制剂开发的重要环节。建立了分光光度法测定药物剂型苯磺酸氨氯地平的方法并进行了验证。苯磺酸氨氯地平的最大波长为360nm。乙醇作为溶剂。苯磺酸氨氯地平在5 ~ 40μg/ml浓度范围内符合比尔斯定律。得到直线方程为y = 0.0136x + 0.001,相关系数(r2)为0.998。研究了日间和日内的变化以确定所提出方法的精度,并发现该方法具有良好的精度,因为%RSD小于2%。对两种不同的市售制剂(A和B)进行了测定,A和B的%测定率分别为98.3%和99.2%。定量限为0.08123µg/ml,定量限为0.2461µg/ml。方法采用线性、准确度、精密度、灵敏度、鲁棒性、坚固性等参数,所有程序均按ICH指南执行。
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UV Spectrophotometric Method Development and Validation for Amlodipine Besylate in Bulk and Tablet Dosage Form
Analytical method development and validation is important in development of pharmaceutical preparations. In present study a spectroscopic method for determination of Amlodipine besylate in pharmaceutical dosage form has been developed and validated. The wavelength maxima of Amlodipine besylate was found to be 360nm. Ethanol was used as a solvent. Amlodipine besylate obeys beers law in the concentration range of 5-40μg/ml. The line equation obtained is y = 0.0136x + 0.001 with correlation coefficient (r2) of 0.998. Interday, intraday variations were studied to determine the precision of the proposed method and was found to be with good precision as the %RSD was less than 2%. The assay of 2 different marketed formulation (A and B) has been performed and the % assay of A and B was found to be 98.3% and 99.2% respectively. The sensitivity of the method was determined by LOD and LOQ was found to be 0.08123µg/ml and 0.2461µg/ml respectively. The method employed the parameters like linearity, accuracy, precision, sensitivity, robustness, ruggedness and all the procedures were as per ICH guidelines.
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