摘要
目的:采用高效液相色谱法测定甲磺酸帕珠沙星原料及其制剂含量。方法:Hypersil C18(5μm,4．6 mm×250 mm) 色谱柱,0．1％磷酸溶液(加磷酸氢二钾80．5 mg)-乙腈(85:15)为流动相,流速1．0 ml·min-1,柱温30℃,检测波长243 nm。结果:甲磺酸帕珠沙星在5-500μg·ml-1内与峰面积呈良好的线性关系。甲磺酸帕珠沙星原料(3批)加样回收率99．2％甲磺酸帕珠沙星注射液加样回收率均值为100．1％;甲磺酸帕珠沙星氯化钠注射液加样回收率均值为99．7％。结论:采用 HPLC测定原料及其制剂中甲磺酸帕珠沙星含量方法简便,结果可靠。
Objective： To establish a method for determination the content of pazufloxacin Mesilate＇s raw materials and its preparation by HPLC. Method： The Hypersil C,s column（4.6 mm ×250 mm,μm）was used, the mobile phase was 0. 1% phosphoric acid solution （add dipotassium hydrogen phosphate 80.5 mg） -Acetonitrile （85： 15）, the flow rate was 1.0 ml·min^-1, column temperature at 30 ℃, the detection wavelength was at 243 nm. Result： The pazufloxacin mesilates showed a good linear correlation in the range of 5 -500 μg·ml^-1, the average recoveries of pazufloxacin mesilates raw material, pazufloxacin injection, pazufloxacin sodium chloride ingeetion were 99.2%, 100.1% ,99.7%, respectively. Conclusion： the method is simple, relioble, and can be used for determination the content of pazufloxacin mesilate raw material and its preparation.
出处
《中国药师》
CAS
2005年第12期999-1001,共3页
China Pharmacist
