LC-MS法测定复方药物中苯磺酸氨氯地平和阿托伐他汀钙的含量

Determination of Amlodipine and Atorvastatin Calcium in Compound Medicine by LC-MS

建立了液相色谱-质谱(LC-MS)法测定复方药物中苯磺酸氨氯地平(AML)和阿托伐他汀钙(ATO)的含量。选择C18柱为分离柱;柱温:25℃;流动相为0.1%甲酸水和乙腈溶液;流速1.0 m L/min;进样量20μL;三重四极杆质量分析器检测。结果表明:AML的线性范围为2.5~500.0μg/kg,R^2=0.999 8,定量限为0.125μg/kg,平均回收率分别为87.57%~95.73%,相对标准偏差为3.6%~9.1%;ATO的线性范围为0.5~500.0μg/kg,R^2=0.9997,定量限为0.05μg/kg,平均回收率分别为87.74%~98.27%,相对标准偏差为5.6%~8.7%。该方法灵敏度高,线性范围宽,检测限低,适用于复方药物中有效成分含量的测定。

A method for determination of amlodipine（AML） and atorvastatin calcium（ATO） in compound medicine by high-performance liquid chromatography-mass spectrometry（LC-MS） was developed. The C18 column was used as separating column, the column temperature was at 25 C,the mobile phase was 0.1% formic acid water and acetonitrile,the flow rate was 1.0 m L/min, the injection volume was 20 L, the triple quadrupole mass analyzer was used to determine the sample. The results show that the linear range of AML is 2.5-500.0 μg/kg, and R-2 is 0.999 8, and the limit of quantification is 0.125 μg/kg, and the average recovery rate is 87.57%-95.73%, and the relative standard deviation is 3.6%-9.1%; the linear range of the ATO is 0.5-500.0 μg/kg, R-2=0.999 7, and the limit of quantification is 0.05 μg/kg, and the average recovery rate is 87.74%-98.27%, and the relative standard deviation is 5.6%-8.7%. The method has high sensitivity, wide linear range and low detection limit, and is suitable for determination of active ingredients in compound medicine.