HPLC法测定二氟尼柳缓释片中二氟尼柳含量

Determination of diflunisal in diflunisal sustained release tablets by HPLC

目的建立二氟尼柳缓释片中二氟尼柳含量测定的HPLC法。方法 C18色谱柱(4.6 mm×250 mm,5μm),流动相为甲醇-乙腈-水-冰醋酸(30∶70∶50∶2),检测波长为254 nm,流速为1.5 mL/min,柱温为室温,进样量为10μL。结果二氟尼柳检测浓度的线性范围为7.5～52.5μg/mL(r=0.999 9),平均回收率为99.93%,RSD=0.76%。结论本方法准确、可靠,重现性好,可用于二氟尼柳缓释片中二氟尼柳的含量测定。

Objective To establish an HPLC method for determination of the diflunisal content in diflunisal sustained release tablets. Methods The quantitative analysis was performed on a Hypersil DBS C18 column（4. 6 mm x 250 mm,5 μm）. The mobile phase was methanol-methyl cyanides-water-glacial acetic acid （ 30： 70： 50：2 ） with the flow rate of 1.5 mL/min. The detective wavelength was 254 nm at room temperature. Results The linear range of difluni- sal was 7.5 - 52. 5 g/mL （r = 0. 999 9 ）. The average recovery was 99.93 % , and RSD was 0. 76%. Conclusion The method is accurate and reliable with good reproducibility,it could be used for the quality control for the preparation.