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特定药物制剂中睾酮及睾酮酯的分离与测定

Separation and determination of testosterone and testosterone esters in selected pharmaceutical formulations.

作者信息

Graham R E, Biehl E R, Kenner C T

出版信息

J Pharm Sci. 1979 Jul;68(7):871-5. doi: 10.1002/jps.2600680722.

DOI:10.1002/jps.2600680722
PMID:458606
Abstract

A rapid quantitative procedure is presented for the separation of testosterone esters from their hydrolysis products through the use of the acetonitrile-infusorial earth column. The method was applied to testosterone cypionate, testosterone enanthate, and testosterone propionate. Recovery and replication of reference standard testosterone and its three esters through the proposed method ranged from 99.1 to 100.3%, and the percent relative standard deviation ranged from 0.6 to 1.0%. Two samples can be separated into testosterone and testosterone ester fractions in about 1.5 hr. The analyses of 20 injectable and one buccal tablet formulations made by 12 different manufacturers are reported.

摘要

本文介绍了一种快速定量方法,通过使用乙腈-硅藻土柱从睾酮酯的水解产物中分离出睾酮酯。该方法应用于环戊丙酸睾酮、庚酸睾酮和丙酸睾酮。通过该方法对参考标准睾酮及其三种酯的回收率和重现性范围为99.1%至100.3%,相对标准偏差百分比范围为0.6%至1.0%。两个样品可在约1.5小时内分离为睾酮和睾酮酯馏分。报告了对12个不同制造商生产的20种注射剂和1种口腔片剂配方的分析结果。

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