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高效液相色谱法分析固体剂型中氯氮䓬二钾和氯氮䓬一钾的含量

High-performance liquid chromatographic analysis of clorazepate dipotassium and monopotassium in solid dosage forms.

作者信息

Elrod L, Shada D M, Taylor V E

出版信息

J Pharm Sci. 1981 Jul;70(7):793-5. doi: 10.1002/jps.2600700721.

Abstract

Methodology for the quantitative determination of clorazepate dipotassium and monopotassium in solid dosage forms was developed. Clorazepate was resolved from its degradation products, making the analysis specific and stability indicating. Analytical separation was performed on a octadecylsilylated silica column. Clorazepate was extracted from the dosage forms with 0.04% NaOH and chromatographed with aqueous 0.005 M tetra-n-butylammonium ion (pH 7.5)- acetonitrile (70:30) as the eluent. The analysis was completed in approximately 20 min with a precision of less than 2.4% RSD.

摘要

开发了用于定量测定固体剂型中地西泮二钾和一钾的方法。地西泮与其降解产物分离,使分析具有特异性且为稳定性指示分析。分析分离在十八烷基硅烷化硅胶柱上进行。用地西泮从剂型中提取,并用0.005 M四丁基铵离子(pH 7.5)-乙腈(70:30)水溶液作为洗脱剂进行色谱分析。分析在约20分钟内完成,相对标准偏差小于2.4%。

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