氟雷拉纳咀嚼片溶出度的测定

Determination of dissolution of fluralaner chewable tablets

为了建立氟雷拉纳咀嚼片的溶出度检测方法,通过筛选不同pH值的缓冲液及含有不同质量浓度表面活性剂的溶出介质,绘制本品中氟雷拉纳的体外溶出曲线。溶出方法为桨法,转速为75 r/min;检测方法为高效液相色谱法,采用Eclipse Plus C18(4.6 mm×250 mm,5μm)色谱柱,以水与乙腈的液相体积比25∶75为流动相,检测波长为210 nm,流速1.0 m L/min,柱温35℃。结果显示,氟雷拉纳在33.6~336μg/m L范围内与检测峰面积呈良好的线性关系,其平均回收率为100.03%,溶出介质选用10 g/L十六烷基三甲基溴化铵时,溶出度不低于标示量的80%。结果表明,该方法简单、灵敏、准确、专属性强,可用于氟雷拉纳咀嚼片溶出度的检测。

The purpose of this paper is to establish the dissolution test method of fluralaner chewable tablets,and to draw the in vitro dissolution curve of fluralaner chewable tablets by screening different pH values of buffers and dissolution media containing different mass concentrations of surfactants.The dissolution method was paddle method with the rotational speed of 75 r/min.The detection method was high performance liquid chromatography using Eclipse Plus C18 column(4.6 mm×250 mm,5μm).The liquid-phase ratio of water to acetonitrile was 25:75 as the mobile phase.The detection wavelength was set at 210 nm,the flow rate was 1.0 mL/min,and the column temperature was 35℃.The results showed that the average recovery rate of fluralaner was 100.03% in the range of 33.6 to 336μg/mL.When 10 g/L hexadecyl trimethyl ammonium bromide was used as the dissolution medium,the dissolution degree was not less than 80% of the labeled amount.The experimental results show that the method is simple,sensitive,accurate and specific,and can be used to detect the dissolution of fluralaner chewable tablets.