普卢利沙星胶囊溶出度测定方法的研究

Study on Determination Method of Dissolution Rate of Prulifloxacin Capsules

目的：建立普卢利沙星胶囊剂溶出度的测定方法。方法：采用转蓝法，以1000mL盐酸溶液（9→1000）为溶出介质，转速：100r·min-1，45min取样，274nm波长处分光光度法检测。结果：普卢利沙星在1.2-12.3μg·mL-1浓度范围内线性关系良好（r=0.9999，n=5），平均回收率99.7%，RSD为0.37%。结论：采用紫外分光光度法测定普卢利沙星胶囊溶出度的方法操作简便，结果准确，能够用于该药的质量控制。

Obiective：To establish the determination method of dissolution rate of Prulifloxacin Capsules. Methods：The dissolution rate for Prulifloxacin Capsules was detected by using UV spectrophotometry at 274 nm with hydrochloric acid solution（9→1 000）1 000 mL as the dissolution mediator at the rate of 100 r·min - 1 by the stirring basket method,45 min sampling. Results：The calibrated linear curve of Prulifloxacin was good in the range of 1. 2 - 12. 3 μg·mL - 1（r =0. 9 999,n = 5）. The average recovery rate was 99. 7 % with RSD of 0. 37% . Conclusion：The method is proved to be accurate and reliable for the quality control of Prulifloxacin capsules.