OBJECTIVE To develop a LC-MS method with direct precipitation of sample protein to determinate the concentration of pitavastatin in human plasma. METHODS LC-MS equipment with ESI source and Waters Cosmosil Packed Coulmn C18-MS-Ⅱ(2.0 mm×150 mm， 5 μm were used in the experiment. The column temperature was set at 40 ℃. 10 mmol·L-1 ammonium formate (contain 0.1% formic acid-acetonitrile(40∶60 was used as mobile phase and the flow rate was 0.3 mL·min-1. The sample room temperature was set at 15 ℃ and the injection volume was 20 μL. Rosuvastatin was taken as the internal standard. RESULTS Pitavastatin was linear in the range of 0.5-1 000 ng·mL-1. The limitation of detection for pitavastatin was 0.1 ng·mL-1. The method was sensitivity， stability and specificity and was used for pharmacokinetic study of pitavastatin in human successfully. CONCLUSION The method is simple， accurate， reproducibility for the determination of pitavastatin in human plasma and suitable for the study in pharmacology.
CHEN Yo;TN Zhi-rong;ZHOU Gn;OU-YNG Dong-sheng;ZHNG Jin;ZHOU Hong-ho.
LC-MS Determination of Pitavastatin in Human Plasma and Its Application[J]. Chinese Pharmaceutical Journal, 2011, 46(2): 134-137
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