高效液相色谱法测定复方片剂中奋乃静和盐酸阿米替林的含量。

High-performance liquid chromatographic determination of perphenazine and amitriptyline hydrochloride in two-component tablet formulations.

作者信息

Butterfield A G, Sears R W

出版信息

J Pharm Sci. 1977 Aug;66(8):1117-9. doi: 10.1002/jps.2600660816.

Abstract

A rapid, precise, and accurate high-performance liquid chromatographic procedure is presented for the simultaneous determination of perphenazine and amitriptyline hydrochloride in two-component tablet formulations. An aliquot of a methanolic extract of the tablet, containing trifluoperazine hydrochloride as an internal standard, is chromatographed on a nitrile bonded phase microparticulate column using a 0.005 M ammonium acetate-methanol (20:80) mobile phase. Quantitation is by peak area. The relative standard deviations for the procedure are 0.34 and 0.54% for the simultaneous determination of perphenazine and amitriptyline, respectively. Eight commercial tablet formulations were analyzed and found to contain 96.5-101.5 and 96.5-103.3% of the labeled amounts of perphenazine and amitriptyline hydrochloride, respectively.

摘要

本文介绍了一种快速、精确且准确的高效液相色谱法，用于同时测定两组分片剂制剂中的奋乃静和盐酸阿米替林。取含有盐酸三氟拉嗪作为内标的片剂甲醇提取物的等分试样，使用0.005M醋酸铵 - 甲醇（20:80）流动相在腈基键合相微粒柱上进行色谱分析。通过峰面积进行定量。该方法同时测定奋乃静和盐酸阿米替林的相对标准偏差分别为0.34%和0.54%。对8种市售片剂制剂进行了分析，发现其奋乃静和盐酸阿米替林的含量分别为标示量的96.5 - 101.5%和96.5 - 103.3%。