方波伏安法同时测定制剂中氨氯地平和瑞舒伐他汀的含量

B. Yılmaz, Nurullah Yilmaz
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引用次数: 2

摘要

目的:建立一种快速、简便、精确、特异的方波伏安法同时测定药物制剂中氨氯地平(AML)和瑞舒伐他汀(ROS)含量的方法。方法:采用铂盘电极,研究AML和ROS的电化学行为和同时伏安测定。根据ICH指南对特异性、线性、准确度、精密度、坚固性、稳定性、定量限和检出限等验证参数进行了研究。结果:该方法在5 ~ 40 μg/mL浓度范围内线性良好。AML和ROS的精密度分别小于1.88和1.93%,相对误差分别在1.69和1.97%以内。药物制剂中AML和ROS的回收率分别为99.5%和100.2%。AML的检测限和定量限分别为0.70和2.10µg/mL, ROS的检测限和定量限分别为0.80和2.40µg/mL。结论:所建立的SWV方法可用于药物制剂中AML和ROS的常规分析。
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Simultaneous Determination of Amlodipine and Rosuvastatin in Pharmaceutical Preparations by Square Wave Voltammetry
Objectives: In this work, a new, rapid, simple, precise and specific method has been developed for the simultaneous determination of amlodipine (AML) and rosuvastatin (ROS) in pharmaceutical preparations by square wave voltammetry (SWV). Methods: Electrochemical behavior and simultaneous voltammetric determination of AML and ROS were investigated using platinum disk electrode. Validation parameters such as specificity, linearity, accuracy, precision, ruggedness, stability, limit of quantification and limit of detection were studied according to the ICH Guidelines. Results: The linearity of this developed method was established in the concentration range of 5-40 μg/mL for AML and ROS, respectively. The precision was less than 1.88 and 1.93%, determined from quality control samples for AML and ROS, and accuracy was within 1.69 and 1.97% in terms of relative error, respectively. The percentage recovery obtained for AML and ROS in pharmaceutical preparations were 99.5 and 100.2%, respectively. Limit of detection and quantification for AML were 0.70 and 2.10 µg/mL, for ROS 0.80 and 2.40 µg/mL, respectively. Conclusion: The developed SWV method can be used for routine analysis of AML and ROS in pharmaceutical preparations.
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