Simultaneous Determination of Amlodipine and Hydrochlorothiazide in Pharmaceutical Preparations by Differential Pulse Voltammetry Method

B. Yılmaz, Umit Kocak
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Abstract

Objectives: In this study, a new, fast and reliable differential pulse voltammetry (DPV) method was developed and validated for the simultaneous determination of amlodipine (AML) and hydrochlorothiazide(HCT) in pharmaceutical preparations. Methods: Electrochemical behavior and simultaneous voltammetric determination of AML and HCT  were investigated using glassy carbon electrode. Validation parameters such as specificity, linearity, accuracy, precision, ruggedness, stability, limit of quantification and limit of detection were studied according to the International Conference on Harmonisation (ICH) Guidelines. Results: The linearity of this developed method was established in the concentration range of 2.5-30 μg/mL for AML and HCT, respectively. The precision was less than 5.34 and 2.91 %, determined from quality control samples for AML and HCT, and accuracy was within 2.57 and 3.60 % in terms of relative error, respectively. The percentage recovery obtained for AML and HCT in pharmaceutical preparations were 99.6 and 100.1 %, respectively. Limits of detection and quantification for AML and HCT were 0.80 and 2.40 µg/mL, respectively. Conclusion: The developed DPV method can be used for routine analysis of AML and HCT in pharmaceutical preparations.
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差分脉冲伏安法同时测定药物制剂中氨氯地平和氢氯噻嗪的含量
目的:建立一种快速、可靠的差分脉冲伏安法(DPV),用于同时测定药物制剂中氨氯地平(AML)和氢氯噻嗪(HCT)的含量。方法:采用玻碳电极研究AML和HCT的电化学行为和同时伏安测定。根据国际协调会议(ICH)指南研究了特异性、线性、准确性、精密度、坚固性、稳定性、定量限和检出限等验证参数。结果:AML和HCT在2.5 ~ 30 μg/mL浓度范围内线性良好。AML和HCT质控样品的精密度分别小于5.34%和2.91%,相对误差分别在2.57%和3.60%以内。药物制剂中AML和HCT的回收率分别为99.6%和100.1%。AML和HCT的检测限和定量限分别为0.80µg/mL和2.40µg/mL。结论:所建立的DPV方法可用于药物制剂中AML和HCT的常规分析。
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