Cho Seungil, Jegal Moonyoung, Ohk Boram, Kim Bo Kyung, Gwon Mi-Ri, Kang Woo Youl, Seong Sook Jin, Kim Hyun-Ju, Lee Hae Won, Yoon Young-Ran
Department of Biomedical Science, BK21 Plus KNU Bio-Medical Convergence Program for Creative Talent and Clinical Trial Center, Kyungpook National University Graduate School and Hospital, Daegu 41944, Korea.
Transl Clin Pharmacol. 2017 Jun;25(2):106-111. doi: 10.12793/tcp.2017.25.2.106. Epub 2017 Jun 15.
This study describes the development of an analytical method to determine sumatriptan levels in human plasma using high performance liquid chromatography (HPLC) coupled with triple quadrupole tandem mass spectrometry (MS/MS) and its application to a pharmacokinetic study in healthy Korean volunteers. A single 50 mg dose of sumatriptan was orally administered to twelve healthy volunteers (nine women and three men). The HPLC-MS/MS analytical method was validated with respect to its specificity, linearity, sensitivity, accuracy, precision, recovery, and stability. The calibration curve was linear over a concentration range of 0.3-100 ng/mL ( > 0.999). The lower limit of quantitation for sumatriptan in plasma was 0.3 ng/mL. The accuracy and precision of the analytical method were acceptable within 15% at all quality control levels. We compared plasma concentration-time curves as well as pharmacokinetic parameters such as the area under the curve (AUC) and maximum plasma concentration (C). Both the mean AUC and C of sumatriptan were 1.56 times higher in women than in men. These differences could be largely explained by the difference in body weight (44%) between women and men. The outcomes may provide insights into developing appropriate individualized treatment strategies.
本研究描述了一种采用高效液相色谱(HPLC)与三重四极杆串联质谱(MS/MS)联用测定人血浆中舒马曲坦水平的分析方法的开发及其在健康韩国志愿者药代动力学研究中的应用。向12名健康志愿者(9名女性和3名男性)口服单剂量50 mg舒马曲坦。对HPLC-MS/MS分析方法的特异性、线性、灵敏度、准确性、精密度、回收率和稳定性进行了验证。校准曲线在0.3-100 ng/mL的浓度范围内呈线性(>0.999)。血浆中舒马曲坦的定量下限为0.3 ng/mL。在所有质量控制水平下,分析方法的准确性和精密度在15%以内是可接受的。我们比较了血浆浓度-时间曲线以及药代动力学参数,如曲线下面积(AUC)和最大血浆浓度(C)。舒马曲坦的平均AUC和C在女性中比男性高1.56倍。这些差异很大程度上可以由女性和男性之间体重的差异(44%)来解释。这些结果可能为制定适当的个体化治疗策略提供见解。