论文部分内容阅读
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 determine the content of pazufloxacin mesylate and its preparation by high performance liquid chromatography. METHODS: The mobile phase was Hypersil C18 (5μm, 4.6 mm × 250 mm) column, 0.1% phosphoric acid solution (80.5 mg potassium phosphate dibasic) -acetonitrile (85:15) ml · min-1, column temperature 30 ℃, detection wavelength 243 nm. Results: Pazufloxacin mesylate showed a good linear relationship with the peak area in 5-500μg · ml-1. Pazufloxacin mesylate raw materials (3 batches) sample recovery rate of 99.2% Pazufloxacin mesylate injection sample recovery was 100.1%; pazufloxacin mesylate sodium chloride The average injection recovery rate was 99.7%. Conclusion: HPLC method for the determination of pazufloxacin mesylate in raw materials and their preparations is simple and reliable.