加替沙星软胶囊溶出度的测定方法研究

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HCI（9→1000）溶液900ml为溶出介质，转速为100r／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。

Research on determination of dissolution of gatifioxacin Gatifioxacin Capsules

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.