Abdel-Ghany Maha F, Ayad Miriam F, Tadros Mariam M
Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Abbassia, Cairo 11566, Egypt.
Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Abbassia, Cairo 11566, Egypt.
J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Jul 15;1058:93-101. doi: 10.1016/j.jchromb.2017.04.043. Epub 2017 Apr 26.
A new fast LC-MS/MS method was developed for determination of alogliptin and pioglitazone in human plasma. Linearity ranges of 10-400ngmL for alogliptin and 25-2000ngmL for pioglitazone, were found to be suitable for their bioanalysis covering the C and C values of the drugs. Direct precipitation technique was used for simultaneous extraction of the drugs successfully from human plasma samples. Chromatographic separation was achieved on a BEH C column (50mm×2.1mm, 1.7μm) with 0.1% aqueous formic acid: acetonitrile (40:60, v/v) at a flow rate of 0.3mLmin. The validated method was applied to a preliminary pharmacokinetic study on human volunteers. Monitoring the transition pairs of m/z 340.18 to 116.08 for alogliptin and m/z 356.99 to 133.92 for pioglitazone, using triple quadrupole mass spectrometer with multiple reaction monitoring, was achieved in the positive mode. The validated method is accurate and suitable for further clinical applications and possible bioequivalence studies.
开发了一种新的快速液相色谱-串联质谱法用于测定人血浆中的阿格列汀和吡格列酮。发现阿格列汀的线性范围为10 - 400ng/mL，吡格列酮的线性范围为25 - 2000ng/mL，适用于涵盖药物Cmax和AUC值的生物分析。采用直接沉淀技术成功地从人血浆样品中同时提取药物。在BEH C18柱（50mm×2.1mm，1.7μm）上，以0.1%甲酸水溶液：乙腈（40:60，v/v）为流动相，流速为0.3mL/min进行色谱分离。经验证的该方法应用于人体志愿者的初步药代动力学研究。在正离子模式下，使用三重四极杆质谱仪的多反应监测模式监测阿格列汀的m/z 340.18至116.08和吡格列酮的m/z 356.99至133.92的过渡对。经验证的该方法准确，适用于进一步的临床应用和可能的生物等效性研究。
