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.%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1000 mL 盐酸溶液(9→1000)为溶出介质,转速:100 r·min -1,45 min 取样,274 nm 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。
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