HPLC法测定癸氧喹酯固体分散体有关物质及其含量

Determination of decoquinate dispersions of solid by HPLC method

采用高效液相色谱(HPLC)法测定癸氧喹酯固体分散体的有关物质及含量,用C18色谱柱(Dionex5μm,4.6 mm×250 mm),以无水甲醇为流动相,流动相速度为1.0 mL/min,柱温为30℃,检测波长为265 nm.结果发现癸氧喹酯固体分散体在1.0～50 mg/mL浓度范围内呈良好线性关系(R2=0.999 8);平均回收率为101.3%;RSD为0.84%;检测线为0.05 mg/mL.结果表明:本法可快速、准确地测定癸氧喹酯固体分散体的含量和有关物质,适用于产品的质量控制.

Established a method for determination of decoquinate disperisions of solid with high performance liquid chromatography（HPLC）.The HPLC method was carried on C18（4.6 mm×250 mm,5 μm） column using anhydrous methanol as mobile phase.The flow rate was 1 mL/min.The column temperature was 30 ℃ and detection wavelength was 265 nm.The result showed the calibration curve for decoquinate dispersions of solid was linear in the range of 1.0-50 mg/mL（R2=0.999 8）.The average recovery of decoquinate dispersions of solid was 101.3%,with RSD 0.84%,the detected limit was 0.05 mg/mL.The method which was rapid,simple,accurate and suitable for the quality control of the drug was found in the research.