HPLC法测定二氟尼柳缓释片中二氟尼柳含量

摘要

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 × 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 diflunisal 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.%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,5 μm),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10 μL.结果 二氟尼柳检测浓度的线性范围为7.5~52.5 μg/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.