司帕沙星注射剂的制备及质量控制

Preparation and quality control of sparfloxacin for injection

目的制备司帕沙星注射液,建立质量控制标准。方法以司帕沙星为原料,葡萄糖酸内酯为酸度调节剂,制成注射剂,用高效液相色谱法测定其含量。结果司帕沙星注射液在20-60μg/ml范围内重现性良好,平均回收率99.74%,RSD为0.15%。结论该制剂方法制备方法简单,含量测定准确可靠。

Objective To establish a standard for preparing sparfluxacin injection and controlling its quality.Methods The sparflo-xacin for injection was prepared with sparfloxacin as a raw material and delta-gluconolactone as an acidity regulator.The content of sparfloxacin in injection was measured using HPLC.Results There was a good linear relationship between concentration of sparfloxacin and absorbance in the range of 20-60 μg/ml.The recovery rate was 99.53%,and RSD was 0.53%.Conclusion This method for preparing sparfluxacin injection is simple,accurate and reliable for quality control.