HPLC-MS/MS法测定人血浆中匹伐他汀钙的浓度及应用

目的建立高效液相色谱-质谱（HPLC-MS/MS）法测定人血浆中匹伐他汀钙的浓度,评价2种匹伐他汀钙片在人体内的生物等效性。方法血浆中加入内标瑞舒伐他汀后,甲基叔丁基醚萃取,选用Venusil MP-C18（150 mm×2.1 mm,5μm,Agela）色谱柱,流动相为30 mmol·L-1乙酸铵（含0.1%甲酸）-甲醇（25：75）,流速0.4 mL·min-1,进样体积为20μL,柱温为40℃。以多重离子反应监测模式进行检测：m/z421.9→m/z290.1（匹伐他汀）,m/z482.2→m/z258.2（瑞舒伐他汀）。结果匹伐他汀钙的线性范围为0.110～56.0μg·L-1,本方法灵敏、稳定、特异性高,可应用于生物等效性研究。结论该方法重复性好,可以准确测量人血浆中匹伐他汀钙的浓度,适用于临床匹伐他汀的生物等效性研究。

Determination of pitavastatin concentration in human plasma by HPLC-MS/MS

Objective To establish an HPLC-MS/MS method to detemine the concentration of pitavastatin calcium in human plasma.Methods After the internal standard rosuvastatain was added in the plasma,methy tert-butyl ether was used for extraction.The analysis involved a Venusil MP-C18（150 mm×2.1 mm,5 μm,Agela）,with the mobile phase consisting of 30 mmmol·L-1 ammonium acetate（0.1% formic acid）-methanol（25 ：75）.The flow rate was 0.4 mL·min-1,the injection volum was 20 μL,and the column temperature was 40 ℃.Results The peak area of pitavastatin in the plasma showed a good linearity at 0.110-56.0 μg·L-1.Conclusion The method is feasible for measuring the plasma concentration of pitavastatin in human accurately and can be used in the bioequivalence study of pitavastatin.