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片剂的非水滴定法含量均匀度检查

Content uniformity test of tablets by nonaqueous titration method.

作者信息

Safarík L

出版信息

Pharmazie. 1987 Feb;42(2):129-30.

PMID:3602052
Abstract

For the Content uniformity test (CUT) of tablets where the active drug behaves in a nonaqueous medium as a base a very simple method was developed. This method is based on the extraction of the active drug from the tablet into anhydrous acetic acid and direct titration of the solute with HClO4 (0.1 or 0.05 mol/l solution in anhydrous acetic acid). The course of the titration is followed potentiometrically with a glass and calomel electrode coupled and recorded automatically with a suitable registration potentiometer. The method was successfully applied to samples of commercial tablets containing the following drugs: codeine phosphate, embramine, ephedrine, ethylmorphine, pyridoxine, thiamine and tolazoline, all as hydrochlorides. It can be used also for several other drugs.

摘要

对于活性药物在非水介质中呈碱性的片剂的含量均匀度测试(CUT),开发了一种非常简单的方法。该方法基于将片剂中的活性药物萃取到无水乙酸中,并用高氯酸(0.1或0.05 mol/l无水乙酸溶液)直接滴定溶质。滴定过程通过连接玻璃电极和甘汞电极进行电位监测,并用合适的记录电位计自动记录。该方法已成功应用于含有以下药物(均为盐酸盐)的市售片剂样品:磷酸可待因、安溴铵、麻黄碱、乙基吗啡、吡哆醇、硫胺素和妥拉唑啉。它也可用于其他几种药物。

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