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目的建立血浆中尼伐地平对映体的HPLC法。方法在弱碱性条件下,血浆样品用环己烷-异丙醇(96.5∶3.5,V/V)混合溶剂提取,以卵类糖蛋白为固定相,以含乙醇22.5%的50 mmol.L-1磷酸盐缓冲液(pH 5.1)为流动相,采用HPLC法分离测定,检测波长236 nm。结果在本实验条件下,血浆内源性物质无干扰,尼伐地平对映体可在30 min内得到基线分离。检测信号峰面积与(S)-(+)或(R)-(-)尼伐地平在10~300μg.L-1内呈良好的线性关系,检测限约为3μg.L-1,方法回收率为91.7%~100.5%,RSD<9.8%。结论本方法具有简便快速、精密度和准确度好的优点,可用于血浆中尼伐地平对映体的分离和测定。
OBJECTIVE To establish an HPLC method for enantioseparation of nilvadipine in plasma. Methods The plasma samples were extracted with mixed solvent of cyclohexane and isopropanol (96.5: 3.5, V / V) under the condition of weak alkaline. Using the egg glycoprotein as the stationary phase, the plasma samples were extracted with 50 mmol.L -1 phosphate buffer (pH 5.1) as the mobile phase and separated by HPLC. The detection wavelength was 236 nm. Results Under the experimental conditions, the plasma endogenous substances did not interfere, and the enantiomers of nilvadipine could be separated within 30 minutes. The detection signal peak area showed a good linear relationship with (S) - (+) or (R) - (-) nilvadipine in the range of 10 ~ 300μg.L-1 with the detection limit of 3μg.L-1. Rates ranged from 91.7% to 100.5% with RSD <9.8%. Conclusion The method is simple, rapid, accurate and accurate. It can be used for the separation and determination of enantiomers of nilvadipine in plasma.