| HPLC-MS/MS测定人血浆中伏立康唑质量浓度及其生物等效性研究 |
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| 引用本文： | 向 瑾,余 勤,梁茂植,等. HPLC-MS/MS测定人血浆中伏立康唑质量浓度及其生物等效性研究[J]. 四川大学学报(医学版), 2018, 49(1): 102-106 |
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| 作者姓名： | 向 瑾 余 勤 梁茂植 等 |
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| 作者单位： | 1.四川大学华西医院 临床药理研究室 |
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| 摘 要： | 目的 建立高效液相色谱-串联质谱（HPLC-MS/MS）法测定人血浆中伏立康唑的方法，并进行伏立康唑片生物等效性研究。方法 采用双周期随机交叉自身对照试验设计，48例健康男性受试者分别单次空腹口服两种伏立康唑片200 mg，采用HPLC-MS/MS法测定人血浆中伏立康唑质量浓度，以WinNonlin?6.1软件计算主要药动学参数，并评价两种伏立康唑片的生物等效性。结果 伏立康唑标准曲线范围均为1~5 000 ng/mL，日内及日间精密度〔相对标准偏差（RSD）〕均小于11%，准确度在100.00%~109.73%之间，以内标基质效应校准后的伏立康唑基质效应RSD小于15%，萃取回收率大于50%，各项稳定性考察结果合格。伏立康唑峰浓度(Cmax)和药-时曲线下面积(AUC0-t、AUC0-∞)的90%置信区间在80.00%~125.00%等效区间之内，受试制剂与参比制剂间达峰时间(Tmax)差异无统计学意义(P>0.05)。结论 所建立的HPLC-MS/MS方法可用于人血浆中伏立康唑质量浓度的测定，伏立康唑片受试制剂与参比制剂生物等效。
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Determination of Voriconazole in Human Plasma and Its Bioequivalence by HPLC-MS/MS |
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| XIANG Jin,YU Qin,LIANG Mao-zhi,et al. Determination of Voriconazole in Human Plasma and Its Bioequivalence by HPLC-MS/MS[J]. Journal of Sichuan University. Medical science edition, 2018, 49(1): 102-106 |
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| Authors: | XIANG Jin YU Qin LIANG Mao-zhi et al |
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| Abstract: | Objective To develop a high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method for the determination of voriconazole in human plasma and its bioequivalence. Methods 48 healthy male volunteers received a single dose of 200 mg voriconazole tablets in a two period (with two preparations) and randomized crossover bioequivalence study. Their plasma voriconazole was determined using HPLC-MS/MS. The pharmacokinetic parameters and bioequivalence of the two preparations were calculated with WinNonlin?6.1. Results The calibration curve of voriconazole ranged from 1 to 5 000 ng/mL. The HPLC-MS/MS method had less than 11% intra- and inter-day relative standard deviation (RSD), with 100.00% to 109.73% accuracies. The RSD of the matrix effect of voriconazole adjusted with internal standard was less than 15%. The extract recoveries exceeded 50% with good stability. The 90% confidence intervals for the peak concentration (Cmax) and the area under the curve (AUC0-t and AUC0-∞) of voriconazole fell into the bioequivalence range of 80.00%-125.00%. There was no significant difference in peak time (Tmax) between the two preparations. Conclusion HPLC-MS/MS can be used for determination of voriconazole in human plasma. The two tested preparations of voriconazole are bioequivalent. |
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| Keywords: | Voriconazole HPLC-MS/MS Plasma concentration Bioequivalence study |
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