国产盐酸溴己新片溶出度评价

目的：建立高效液相色谱测定氟康唑注射液中有关物质及含量的方法。方法：采用C18柱，流动相为0．63mg·mL^-1甲酸铵溶液-乙腈（80：20），检测波长260nm，柱温40℃。结果：氟康唑及其有关物质在该色谱条件下能够有效分离。有关物质和含量测定浓度分别在5．09～203．6μg·mL^-1和0．5004-2．502mg·mL^-1范围内与峰面积呈良好线性关系（r=0．9999）。平均回收率为99．40％，RSD为0．7％（n=9）。结论：该方法简便快速、灵敏准确，专属性强，可用于氟康唑注射液中有关物质检查和含量测定。

Evaluation of Dissolution of Domestic Bromhexine Hydrochloride Tablets

To establish an HPLC method for determination of the content and the related substances of Fluconazole Injec tion. Methods： The method was performed on a Cls column, using mobile phase consisted of 0. 63 mg . mL-1 ammonium formate solu tion-acetonitrile（80： 20）. The detection wavelength was 260 nm and the column temperature was d0 ℃. Results： The linear ranges was 5. 09-203.6 Ug .mL-1 （ r = 0. 9999） for related substances, 0. 5004 - 2. 502 mg . mL- 1 （ r = 0. 9999 ） for assay, the mean recovery was 99.40%, RSD was 0. 7% （n = 9）. Conclusion： The method is sensitive, accurate and high specific for content determination of Flu conazole and its retated substance in Fluconazole Injection.