利伐沙班片体外溶出度的测定

Dissolution Detection of Rivaroxaban Tablets in Vitro

目的:HPLC法测定利伐沙班片的体外溶出。方法:采用《中国药典》2020年版溶出度测定第二法,以2 mg/mL十二烷基硫酸钠(SDS)的pH值4.5醋酸盐缓冲液900 mL为溶出介质,转速75 r/min,溶出时间为15 min。使用HPLC法对溶出样品检测,采用Agilent Poroshell EC-C_(18)色谱柱(50 mm×4.6 mm,2.7μm);流动相:0.1%磷酸水溶液-乙腈(73︰27,体积比);流速:1.0 mL/min;检测波长:250 nm;柱温:50℃;进样量:10μL。结果:本方法平均回收率98.5%(n=12),在1.10~22.10μg/mL范围内线性关系良好。结论:方法简便、灵敏、准确、专属性强;可用于利伐沙班片溶出度的检测。

Object:A HPLC method was established to determinate the dissolution of rivaroxaban tablets in vitro.Methods:The dissolution was determined by the second method described in ChP 2020.900 mL of pH 4.52 mg/mL SDS acetate buffer solution were used as dissolution mediums,and the rotation speed was 75 r/min.The dissolution time was 15 min and the dissolution was determined by HPLC.The HPLC column was Agilent Poroshell EC-C_(18) column(50 mm×4.6 mm,2.7μm).The mobile phase was 0.1%phosphoric acid aqueous solution-acetonitrile(73︰27,V/V),with a flow rate of 1.0 mL/min and the detection wavelength of 250 nm.The column temperature was 50℃and the injection volume was 10μL.Results:The average recovery of the method was about 98.5%(n=12)and calibration curves showed good linearity within ranges of 1.10~22.10μg/mL.Conclusion:The method is convenient and sensitive in the dissolution determination of rivaroxaban tablets.