采用高效液相色谱法对盐酸哌替啶制剂进行定量分析。

Quantitation of meperidine hydrochloride in pharmaceutical dosage forms by high-performance liquid chromatography.

作者信息

Das Gupta V

出版信息

J Pharm Sci. 1983 Jun;72(6):695-7. doi: 10.1002/jps.2600720625.

DOI:10.1002/jps.2600720625

Abstract

A high-performance liquid chromatographic (HPLC) method for the quantitative determination of meperidine hydrochloride in pharmaceutical dosage forms was developed. The method is reproducible and precise with relative standard deviations (based on six readings) of 1.2% with hydroxyzine and 0.93% with hydroxyprogesterone caproate as the internal standards. A variety of other active and inactive ingredients which were mixed with meperidine hydrochloride did not interfere with the assay procedure. Among the ingredients tested were acetaminophen, atropine sulfate, disodium edetate, metacresol, phenol, promethazine, and sodium metabisulfite. This method appears to be stability-indicating since a hydrolyzed sample of meperidine showed zero potency and a new peak with a different retention time.

摘要

建立了一种用于定量测定药物剂型中盐酸哌替啶的高效液相色谱（HPLC）方法。该方法具有可重复性和精密度，以羟嗪为内标时相对标准偏差（基于六次读数）为1.2%，以己酸羟孕酮为内标时相对标准偏差为0.93%。与盐酸哌替啶混合的多种其他活性和非活性成分不干扰测定过程。所测试的成分包括对乙酰氨基酚、硫酸阿托品、依地酸二钠、间甲酚、苯酚、异丙嗪和焦亚硫酸钠。该方法似乎具有稳定性指示作用，因为哌替啶的水解样品显示效价为零且出现了一个保留时间不同的新峰。