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用于测定药物制剂中卡托普利的体积法和分光光度法同时验证

Validation of simultaneous volumetric and spectrophotometric methods for the determination of captopril in pharmaceutical formulations.

作者信息

Rahman Nafisur, Singh Manisha, Hoda Nasrul

机构信息

Analytical Research Division, Department of Chemistry, Aligarh Muslim University, Aligarh 202 002, UP, India.

出版信息

Farmaco. 2005 Jun-Jul;60(6-7):569-74. doi: 10.1016/j.farmac.2005.04.005.

DOI:10.1016/j.farmac.2005.04.005
PMID:15927181
Abstract

Simple, sensitive and economical simultaneous volumetric and spectrophotometric methods for the determination of captopril have been developed. The methods were based on the reaction of captopril with potassium iodate in HCl medium. Amaranth was used as indicator to detect the end-point of the titration in aqueous layer. The iodine formed during the titration was extracted into CCl4 and subsequently determined spectrophotometrically at 510 nm. The Beer's law was obeyed in the concentration range of 120-520 microg ml-1. Rigorous statistical analyses were performed for the validation of the proposed methods. The proposed methods were successfully applied to the determination of captopril in dosage forms. Comparison of the means of the proposed procedures with those of reference methods using point and interval hypothesis tests showed no statistically significant difference.

摘要

已开发出简单、灵敏且经济的同时测定卡托普利的容量法和分光光度法。这些方法基于卡托普利在盐酸介质中与碘酸钾的反应。使用苋菜红作为指示剂来检测水层中滴定的终点。滴定过程中形成的碘被萃取到四氯化碳中,随后在510nm处进行分光光度测定。在120 - 520μg ml-1的浓度范围内符合比尔定律。对所提出的方法进行了严格的统计分析以进行验证。所提出的方法已成功应用于剂型中卡托普利的测定。使用点和区间假设检验将所提出方法的平均值与参考方法的平均值进行比较,结果显示无统计学显著差异。

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