用高效液相色谱法测定复方己酸孕酮注射液中两组分的含量

Determination of Two Constituents in Compound Injection Hydroxyprogesterone Caproate by HPLC

本文建立了复方己酸孕酮注射液的高效液相色谱法。在硅胶柱上，以丙酸睾丸素为内标，同时测定复方己酸孕酮注射液中己酸孕酮和戊酸雌二醇的含量。固定相为ＷａｔｅｒｓＰＯＲＡＳＩＬ。柱（１０μｍ），流动相为正己烷－异丙醇（９１：９），己酸孕酮的回收率为１００．０％（ｎ＝６），ＲＳＤ＝０．３６％；戊酸雌二醇回收率为１０２．１８％（ｎ＝６），ＲＳＤ＝０．９５％。

A HPLC method was developed for simultaneous determination of two constituents (hydroxyprogesterone caproate and estradiol valerate) in compound injection hydroxyprogesterone caproate. The chromatographic conditions are: column. waters pnrasil. 10μm: mobil phase,hexane-propanol (91 : 9): internal standard. testosterone propionate: detected at 280nm. The average recovery of hydroxyprogesterone caproate and estradiol valerate was 100. 0% (n=6),RSD=0. 36% and 102.18% (n=6). RSD=0. 95%. respectively. The method is simple, fast and accurate.