来氟米特片溶出度方法的改进研究

Improvement and Study for Dissolution Test of Leflunomide Tablets

关键词:  来氟米特片  溶出度  高效液相色谱法

Key words:  Leflunomide tablets  dissolution  HPLC

摘要:

目的 改进现行来氟米特片溶出度测定方法。方法 通过对溶出介质、转速、取样时间的一系列考察，最终确定采用桨法，以0.5%十二烷基硫酸钠为溶出介质，转速为75 r·min^-1，经45 min取样，采用高效液相色谱法，在210 nm波长下按外标法以峰面积计算溶出度，并对建立的方法进行了方法学验证。结果 来氟米特浓度在0.6~14.3μg·mL^-1内线性关系良好，Y=72.157X+2.748 6，R²=1，平均回收率为98.7%；采用建立方法测试，同一企业产品溶出度均一性良好，对不同企业产品具有良好的区分力。结论 建立方法革除了药典方法中采用的有机溶剂，方便有效，区分力强，可作为来氟米特片质量控制方法。

Abstract:

OBJECTIVE To improve the current method of dissolution test of leflunomide tablets. METHODS After a series of study on the dissolution meidium, rotate speed and samplingtime, the paddle method was used with 0.5% sodium laurysulfate as the dissolution medium at a rotate speed of 75 r·min^-1, dissolution time was 45 min. Then it was determined by HPLC with detection wavelength of 210 nm, calculated dissolution with peak area according to the external standard, finally carried out the methodology validation for the established method. RESULTS The validation result showed that the linear range of leflunomide was 0.57-14.3 μg·mL^-1, Y=72.157X+2.7486, R²=1, The average recovery was 98.7%. The established method can distinguish one company's product form another while the product from the same company have a good uniformity dissolution. CONCLUSION This method can be useful and convenient without using the organic solvent as dissolution medium in the pharmaceutical method, it can be applied to determine dissolution of leflunomide tablets.