摘要
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。
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.
出处
《中国药品标准》
CAS
2014年第1期27-30,共4页
Drug Standards of China
