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高效液相色谱法同时测定复方片剂中利血平和氢氯噻嗪的含量

Simultaneous determination of reserpine and hydrochlorothiazide in two-component tablet formulations by high-performance liquid chromatography.

作者信息

Butterfield A G, Lovering E G, Sears R W

出版信息

J Pharm Sci. 1978 May;67(5):650-3. doi: 10.1002/jps.2600670520.

Abstract

A high-performance liquid chromatographic procedure is presented for the simultaneous determination of reserpine and hydrochlorothiazide in two-component tablet formulations. An aliquot of a tetrahydrofuran extract of the tablet, containing polylythiazide as an internal standard, is chromatographed on a microparticulate silica gel column using a mobile phase of 0.01% (v/v) diethylamine, 5% (v/v) chloroform, and 18% (v/v) 2-propanol in n-hexane. The relative standard deviations are 1.2 and 0.6% for the simultaneous determination of reserpine and hydrochlorothiazide, respectively. Seven commericial tablet formulations were found to contain 92.7--101.0% and 98.3--101.4% of the labeled amounts of reserpine and hydrochlorothiazide, respectively.

摘要

介绍了一种高效液相色谱法,用于同时测定两组分片剂制剂中的利血平和氢氯噻嗪。取含有聚硫噻嗪作为内标的片剂四氢呋喃提取物的等分试样,在微粒硅胶柱上进行色谱分析,流动相为0.01%(v/v)二乙胺、5%(v/v)氯仿和18%(v/v)异丙醇的正己烷溶液。利血平和氢氯噻嗪同时测定的相对标准偏差分别为1.2%和0.6%。发现七种市售片剂制剂中利血平和氢氯噻嗪的含量分别为标示量的92.7%-101.0%和98.3%-101.4%。

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