依普利酮原料及其制剂的含量测定方法改进

目的建立HPLC测定依普利酮原料及其片剂、胶囊含量的方法，为标准改进提供参考。方法采用Shim—packVP—ODS柱（4．6mm×150mm，5μm），以水甲醇-乙腈-三乙胺（50：25：25：0．1）（用冰醋酸调节pH值为5．5）为流动相，检测波长为240nm，流速为1．0mL·min^-1。结果依普利酮在10．10～151．47μg·mL^-1范围内与峰面积呈良好的线性关系（r=0．9999），依普利酮胶囊的平均回收率为100．23％，RSD为0．95％；依普利酮片的平均回收率为100．77％，RSD为0．76％。三批原料的含量测定结果分别是：99．9Yo、99．8％和99．9％；三批片剂的含量测定结果分别是：96．5％、96．89／6和97．4％；三批胶囊的含量测定结果分别是：97．6％、98．3％和98．2％。结论该方法经方法学验证可用于依普利酮原料、片剂、胶囊的质量控制。

Improvement in Determination of Eplerenone and Its Preparations

Objective To establish an HPLC method for the determination of eplerenone and its preparations and provide a reference for standard improvement. Methods The Shim-pack VP-ODS column （4.6 mm× 150 mm, 5μm） was used, with water-methanol- acetonitrile-triethylamine （50 ： 25 ： 25 ： 0.1） （adjusted with acetic acid to pH 5.5） as the mobile phase, the wavelength of detector was 240 nm, the flow rate was 1.0 mL · min^-1. Results There was a good linear relationship with the peak area in the range of 10.10 - 151.47 μg · mL^-1 （r= 0. 9999）. The average recoveries of eplerenone capsules and eplerenone tablets were 10G23% （RSD=0.95%）, and 10G77% （RSD=0.76%）, respectively. The results of determination for three batches of eplerenone were： 99.9%, 99.8% and 99.9%; the results of determination for three batches of eplerenone tablets were： 96.5%, 96.8% and 97.4%; the results of determination for three batches of eplerenone capsules were： 97.6%, 98.3% and 98.2% .Conclusion The methodology validation showed that this method proved to be simple and reliable, and can he used for the quality control of raw materials for eplerenone, eplerenone tablets and eplerenone capsules.