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目的:建立测定人血浆中多潘立酮浓度的高效液相色谱-荧光测定方法,并对多潘立酮片的生物等效性进行评价。方法:以普萘洛尔为内标,血浆样品经两次萃取,采用C_(18)色谱柱、磷酸二氢钠缓冲液(0.02 mol·L~(-1),pH=3.5):乙腈=70:30为流动相,用HPLC-FLD法测定多潘立酮的浓度。20名健康男性志愿者随机自身交叉单次口服受试制剂和参比制剂后测血药浓度,计算各药动学参数和相对生物利用度。结果:在1.0～50.0 ng·ml~(-1)范围内峰比值与浓度线性关系良好(r= 0.992 3),最低定量浓度为1.0 ng·ml~(-1)。绝对回收率为68.6%～77.0%。多潘立酮片的相对生物利用度为(100.5±25.1)%。结论:统计学结果表明两种制剂生物等效。
OBJECTIVE: To establish a method for the determination of domperidone in human plasma by high performance liquid chromatography-fluorescence spectrometry and to evaluate the bioequivalence of domperidone tablets. Methods: Propranolol was used as an internal standard. The plasma samples were extracted twice with C18 column and 0.02 mol·L -1 sodium bicarbonate buffer (pH = 3.5) 70:30 as the mobile phase, the determination of domperidone concentration by HPLC-FLD method. Twenty healthy male volunteers were randomized to take a randomized single oral administration of the test preparation and the reference preparation to measure the concentration of the drug and calculate the pharmacokinetic parameters and the relative bioavailability. Results: There was a good linear relationship between peak ratio and concentration in the range of 1.0-50.0 ng · ml -1 (r = 0.992 3) and the lowest concentration was 1.0 ng · ml -1. The absolute recovery was 68.6% ~ 77.0%. The relative bioavailability of domperidone tablets was (100.5 ± 25.1)%. Conclusions: The statistical results show that both formulations are bioequivalent.