Dorantes A, Stavchansky S
University of Texas at Austin, College of Pharmacy, Pharmaceutics Division 78712-1074.
J Pharm Sci. 1994 Mar;83(3):379-81. doi: 10.1002/jps.2600830322.
A modification of the U.S.P. dissolution method for the quantitation of norethindrone and ethinyl estradiol tablets is proposed. This modification consists of the use of distilled water as the dissolution medium instead of 0.1 N hydrochloric acid (HCl) and/or neutralization of 0.1 N HCl with sodium carbonate prior to analysis. Statistical analysis of the results indicate that there are no significant differences between the dissolution in 0.1 N HCl and the dissolution in distilled water (p < 0.05) for norethindrone and ethinyl estradiol.
提出了一种美国药典中炔诺酮和炔雌醇片定量溶出度方法的改进方法。这种改进包括使用蒸馏水作为溶出介质，而不是0.1N盐酸（HCl），和/或在分析前用碳酸钠中和0.1N HCl。结果的统计分析表明，对于炔诺酮和炔雌醇，在0.1N HCl中的溶出度和在蒸馏水中的溶出度之间没有显著差异（p<0.05）。
