克林霉素磷酸酯软膏剂的高效液相色谱法测定与制剂稳定性  

DETERMINATION OF STABILITY OF CLINDAMYCIN PHOSPHATE GEL BY AN HPLC ASSAY

作　　者：段更利[1] 戴小平 郭仲秋[3] 程务本[1] 

机构地区：[1]上海医科大学药物分析教研室,200032 [2]上海新亚药业公司药物研究所,200041 [3]上海职工医学院,200237

出　　处：《上海医科大学学报》1997年第4期289-291,共3页Journal of Fudan University(Medical Science)

摘　　要：建立1％克林霉素磷酸酯软膏剂高效液相色谱测定法，研究该制剂的稳定性，为进一步开发此药奠定基础。HPLC仪，ShimadzuLC－9A；色谱柱为150mm×6mmID（ODS，5μm）；流动相为乙睛-磷酸盐缓冲液（27：73）；检测波长210nm。结果：工作曲线方程Y=-57.18＋1364．48X，r=0.9997（n＝6）；回收率100.4％；天内天间的相对标准差分别为1.24％、1.80％。在40℃加速试验3个月，3个批号标示量含量分别为101.7％、105.2％及106.0％。强光照射10d，3个批号的标示量含量分别为101.7％、104．1％及105.3％。结论：建立的HPLC法具有简便、快速、准确度高及重现性好等优点；该软膏剂对强光照射不敏感，室温保存稳定，值得开发。PURPOSE To eetablish an HPLC assay and determine stability of 1 % clindamycin phosphate gel, so asto lay the ground - work for further developing the drug preparation.METHODS HPLC assay. HPLC instrument: LC - 9A Shimadzu; Chlumm was 150 mm × 6 mm ID(ODS, 5 μp); Mobile phase was acetonitrile - phosphate buffer (27: 73); Detection wavelength was UV 210nm.RESULTS The regression equation of clindamycin phosphate with the Peak heightS Y to the concentrations X: Y= - 57. 18 + 1 364. 82X, r = 0. 999 7(n = 6); recovery was 100. 4 %; relative standard deviationSof within - day and day - to- day were less than 2. 0 % (n = 3). The labelling amount percentages of three lotsOf specimens were respectively 101. 7 %, 105. 2 % and 106. 0 % in the tests at 40 ℃ for three months as wellas 101. 7 %, 104. 1 % and 105. 3 % in the strong light tests for ten days.CDNCLUSIONS This HPLC assay is proved tO be sensitive, accurate and simple. The gel preparation hasgood stability in the tests at 40 ℃ and in the strong light. Therefore, it is valuable to be developed.

关 键 词：克林霉素磷酸酯 软膏剂 高效液相色谱 稳定性 

分 类 号：R978.1[医药卫生—药品]