摘要
目的:建立加替沙星软胶囊溶出度的测定方法。方法:依照《中国药典》2005年版二部附录溶出度测定项下第二法,以2%SDS的HCl(9→1000)溶液900 ml为溶出介质,转速为100 r/min,采用HPLC法测定。结果:线性关系在2.0～48.0μg/ml范围内,加替沙星浓度与峰面积的线性关系良好(r=0.9999),高中低3种浓度的平均加样回收率分别为102.4%、99.4%及98.7%,RSD为0.97%～2.9%;3批加替沙星软胶囊的溶出度为75.0%～88.0%,且溶出均一性良好。结论:本法操作简便、准确、可靠,适用于加替沙星软胶囊的质量研究。
Objective：To establish a method for determination of the dissolution of gatifioxacin in Gatifioxacin Capsules. Methods： To carry out the dissolution test （Pharmacopoeia of the People＇s Republic of China,Edition 2005 ,Volume 2 ,Appendix, method 2）,using 900 ml HCL solution （9→1000） containing 2%SDS as the solvent,with the rotation speed adjusted to 100 r·min^-1, HPLC was adopted. Results：There was a good linearity of gatifioxacin within the range of 2.0-48.0μ g/ml （r=0.9999）, the average recoveries were 102.4%, 99A%and 98.7% for three different levels of the amount of gatifioxacin,RSD were 0.97%-2.9% ;the dissolution of gatifioxaein in three batches Gatitioxacin Capsules were 75.0%-88.0%. And their dissolution homogeneity was good. Conclusion：This method is simple, quick, accurate and suitable for the quality controt of GatiEoxacin Capsules.
出处
《现代医药卫生》
2009年第14期2090-2092,共3页
Journal of Modern Medicine & Health
