恩诺沙星片含量均匀度测定方法的建立

Establishment of Test for Content Uniformity in Enrofloxacin Tablets

目的:为了建立恩诺沙星片中恩诺沙星含量均匀度的测定方法。方法:采用高效液相色谱法,以0.025 mol/L磷酸溶液(用三乙胺调节pH值至3.0)-乙腈(83∶17)为流动相,色谱柱为Waters Xbridge C18(250 mm×4.6 mm,5μm),流速为1.0 mL/min,柱温为35℃,检测波长为278 nm;进样体积为10μL。结果:恩诺沙星的峰面积积分值在20.50~102.52μg/mL范围内具有良好的线性关系(r=0.9999),平均回收率达到99.9%,RSD=0.4%,含量均匀度的平均值(A+2.2S)分别为98.4%(5.2)、93.2%(11.0)、95.5%(10.1)、107.1%(14.8)。结论:该方法简便、准确、可靠,适用于恩诺沙星片含量均匀度的测定。

Objective:To establish the method for content uniformity of compound enrofloxacin tablets.Method:The mobile phase is 0.025 mol/L phosphoric acid solution(adjust pH to 3.0 with triethylamine)-acetonitrile(83:17),the HPLC column is Waters XbridgeC18 column(250 mm×4.6 mm),the flow.rate is 1.0 mL/min,the column temperature is 35°C,the detection wavelength at 278 nm,and injection volumes are 10μL.Result:The linear range of syringing is 20.50~102.52μg/mL(r-0.9999).The average recovery(n=9)is 99.9%(RSD=0.4%),the averages(A+2.2S)of the content uniformity are 98.4%(5.2)、93.2%(11.0)、95.5%(10.1)、107.1%(14.8).Conclusion:The method is simple,accurate,reliable and suitable for content uniformity determination of enrofloxacin tablets.