中国药房2012，Vol.23Issue(9)：841-843,3.DOI:10.6039/j.issn.1001-0408.2012.09.26
复方醋酸甲地孕酮片的溶出度研究
Study on the Dissolution of Compound Megestrol Acetate Tablets
摘要
Abstract
OBJECTIVE: To establish the method for dissolution test of Compound megestrol acetate tablets. METHODS: Dissolution method was set up by investigating the dissolution medium, rotation speed, dissolution time, etc. The contents of megestrol acetate and ethinyloestradiol in samples were determined by HPLC using UV detector (288 nm) and fluorescence detector (ex-cition wavelength of 285 nm, emission wavelength of 310 nm). Accumulative drug release rate was calculated. RESULTS: 0.5% sodiumdoecylsulfate was used as the dissolution medium and the rotation speed was 75 r·min-1. The sampling time was 60 min. The linear range of megestrol acetate and ethinyloestradiol were 0.394 1-3.941μg·mL-1 (r=1.000 0) and 0.014 32~0.143 2 μg· mL-1 (r=0.999 9). The average recovery was 98.8% and 99.6% (RSD=0.4% and 0.3% , n=9), respectively. CONCLUSION: The established method for dissolution test is specific, sensitive, rapid and accurate, which can be used for dissolution test of Compound megestrol acetate tablets.关键词
复方醋酸甲地孕酮片/醋酸甲地孕酮/炔雌醇/溶出度/高效液相色谱法/桨法Key words
Compound megestrol acetate tablets/ Megestrol acetate/ Ethinyloestradiol/ Dissolution/ HPLC/ Paddle method分类
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闻宏亮,简龙海,宋冬梅,杨永健..复方醋酸甲地孕酮片的溶出度研究[J].中国药房,2012,23(9):841-843,3.
