GC测定非诺贝特制剂中十二烷基硫酸钠含量

Determination of Sodium Dodecyl Sulfate in Fenofibrate Formulation by GC

关键词:  非诺贝特制剂  十二烷基硫酸钠  含量测定  气相色谱法

Key words:  Fenofibrate formulation  sodium dodecyl sulfate  content determination  GC

摘要:

目的 建立非诺贝特制剂中十二烷基硫酸钠的GC测定方法。方法 采用HP-5（30 m×0.53 mm，2.65 μm）毛细管柱，以氮气为载气，氢火焰离子化检测器，程序升温，直接进样，以十二烷醇为对照品外标法测定十二烷基硫酸钠的含量。结果 十二烷醇在0.165~1.32 mg·mL^-1内具有良好的线性关系，相关系数为0.999 5。国内企业产品的十二烷基硫酸钠用量远低于安全用量，但部分国内企业可能存在过量添加和非法添加的问题。结论 本方法准确，专属性强，可作为非诺贝特制剂中十二烷基硫酸钠的检测方法。

Abstract:

OBJECTIVE To establish a method for the sodium dodecyl sulfate determination of Fenofibrate formulation. METHODS The capillary column was HP-5 (30 m×0.53 mm, 2.65 μm). The carrier gas was nitrogen and the detector was FID with temperature programming and direct sample injection. The content of sodium dodecyl sulfate was determined by external standard method with 1-dodecanol as reference substance. RESULTS There was good linear relationship of 1-dodecanol in the concentration range of 0.165-1.32 mg·mL^-1, r=0.9995. The dosage of sodium dodecyl sulfate was lower than the safe amount, but some companies might have overadded or illegally added sodium dodecyl sulfate in our country. CONCLUSION The method is accurate, reliable and suitable for the determination of sodium dodecyl sulfate in Fenofibrate formulation.