Methods of control and standardization of drugs containing progestogen hormones (A review)

Abstract

The group of progestogen hormones includes progesterone (corpus luteum hormone) and a number of synthetic preparations with a structure close to that of progesterone (norethisterone, lynestrenol, levonorgestrel, desogestrel, etc.).The process of state control of the commercial progestogen hormonal preparations and the corresponding normative documentation are not free of significant drawbacks (in particular, some documents operative in the Russian Federation do not regulate the contents of related steroids). For this reason, the problems pertaining to the increase in the level of standardization and control of the quality of progestogen hormonal preparations require permanent attention and thorough consideration.A lot of information concerning the analysis of progestogen hormones is contained in the monograph of G6rrg [1]. However, there are some new data accumulated since that publication.The main methods used for the analysis of progesterone and related drugs were reviewed in [2].An analysis of the published data shows that the authenticity of ethisterone [3][4][5], norethisterone [4,5], and hydroxyprogesterone capronate [5] is established using a color reaction with sulfuric acid; levonorgestrel is identified by its reaction with m-dinitrobenzene in alkaline medium [5]; ethis-I State Research Institute of Drug Standardization and Control, Ministry of Health and Medical Industry, Moscow, Russia.