动力学分光光度法测定药物制剂中的雷米普利
Kinetic spectrophotometric method for the determination of ramipril in pharmaceutical formulations.
作者信息
Rahman Nafisur, Ahmad Yasmin, Azmi Syed Najmul Hejaz
机构信息
Department of Chemistry, Aligarh Muslim University, Aligarh-202002, Uttar Pradesh, India.
出版信息
AAPS PharmSciTech. 2005 Oct 27;6(3):E543-51. doi: 10.1208/pt060368.
The objective of this research was to develop a kinetic spectrophotometric method for determination of ramipril in pure form and pharmaceutical formulations. The method was based on the reaction of carboxylic acid group of the drug with a mixture of potassium iodate (KIO3) and potassium iodide (KI) in aqueous medium at room temperature. The reaction is followed spectrophotometrically by measuring the increase in absorbance at 352 nm as a function of time. The initial-rate and fixed-time methods were adopted for constructing the calibration curves. Both the calibration curves were linear in the concentration range of 10.0-70.0 microg mL(-1). The detection limits were 0.02 microg mL(-1) and 0.15-microg mL(-1) for initial rate and fixed time methods, respectively. The proposed methods are validated statistically and through recovery studies. The point and interval hypothesis tests have been performed confirming that there is no significant difference between the proposed methods and the reference method. The experimental true bias of all samples is less than +/- 2%. The methods have been successfully applied to the determination of ramipril in tablets and capsules.
本研究的目的是开发一种动力学分光光度法，用于测定纯品和药物制剂中的雷米普利。该方法基于药物的羧基与碘酸钾（KIO₃）和碘化钾（KI）的混合物在室温下于水介质中的反应。通过在352 nm处测量吸光度随时间的增加来进行分光光度法跟踪反应。采用初始速率法和固定时间法构建校准曲线。两条校准曲线在10.0 - 70.0 μg mL⁻¹的浓度范围内均呈线性。初始速率法和固定时间法的检测限分别为0.02 μg mL⁻¹和0.15 μg mL⁻¹。所提出的方法通过统计学验证和回收率研究进行了验证。进行了点和区间假设检验，证实所提出的方法与参考方法之间没有显著差异。所有样品的实验真实偏差小于±2%。这些方法已成功应用于片剂和胶囊中雷米普利的测定。
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