高效液相色谱法测定热感赛比斯坦颗粒中吗啡含量

Determination of morphine content in Regan Saibisitan Granules by high performance liquid chromatography

建立高效液相色谱法测定热感赛比斯坦颗粒中的吗啡含量。采用Waters RP-C_(18)色谱柱(250 mm×4.6 mm,5μm)为分离柱,以乙腈-0.01 mol/L磷酸二氢钾和0.05 mol/L庚烷磺酸钠混合溶液(pH 3.5)(体积比为5∶95)为流动相,流量为1.0 mL/min,检测波长为230 nm,柱温为28℃。吗啡的质量浓度在0.24~23.70μg/mL范围内与色谱峰面积线性关系良好,相关系数为0.9999,方法检出限为0.14μg/mL,定量限为0.22μg/mL。样品加标平均回收率为99.05%,测定结果的相对标准偏差为1.62%。该方法适用于热感赛比斯坦颗粒及原料药材罂粟壳中吗啡含量的测定。

A method for the determination of morphine content in Regan Saibisitan Granules by high performance liquid chromatography was established.The Waters RP-C_(18) column(250 mm×4.6 mm,5μm)was used as separation column,a mobile phase was a mixture of acetonitrile-0.01 mol/L potassium dihydrogen phosphate and 0.05 mol/L sodium heptanesulfonate(pH 3.5)(volume ratio was 5∶95),and the flow rate was 1.0 mL/min.The detection wavelength was 230 nm.The column temperature was 28℃.The mass concentration of morphine had a good linear relationship with the chromatographic peak area in the range of 0.24-23.70μg/mL,the correlation coefficient was 0.9999.The detection limit of the method was 0.14μg/mL,and the quantification limit was 0.22μg/mL.The average recovery of sample spiked was 99.05%,and the relative standard deviation of the determination results was 1.62%.The method is applicable for the determination of morphine content in Regan Saibisitan Granules and raw material Poppy shells.