高效液相色谱法测定乙酰甲喹注射液的含量

Determination of Mequindox Injection by HPLC

为建立HPLC法测定乙酰甲喹注射液含量的方法,试验选用Sunfire C18色谱柱,检测波长为254 nm,流动相采用磷酸二氢钾溶液(0.01 mol/L)(pH=6.0)∶乙腈为90∶10,流速为1.0mL/min,柱温30℃。结果显示,浓度在0.01032～0.10320 mg/mL的范围内,峰面积与测定浓度呈良好的线性关系,r=0.9996,加样平均回收率为99.5%,重复性试验RSD为0.3%,最低检出限为1.2 ng。该方法简便、准确、可行,可用于乙酰甲喹注射液的质量控制。

To establish HPLC method for determination of mequindox injection. Use a Sunfire C18 column packed with octadecylsilane bonded silica gel. Detection wavelength was 254 nm. The mobile phase consisted of a mixture of potassium dihydrogen phosphate buffer （0.01 mol/L） （pH = 6.0） and aeetonitrile with a proportion of 90 ： 10, flow rate was 1.0 mL/min, the column temperature was 30 ℃. The calibration curve of Maquindox was linear within the range of 0. 01032 - 0. 10320 mg/mL, r = 0. 9996, The mean recovery rate is 99.5% , The RSD of precision was 0.3 %, The detection limit was 1.2 ng. This method is simple, accurate and reproducible. It can be used to control the quality of mequindox injection.