Quantification of irinotecan, SN38, and SN38G in human and porcine plasma by ultra high-performance liquid chromatography-tandem mass spectrometry and its application to hepatic chemoembolization.
Quantification of irinotecan, SN38, and SN38G in human and porcine plasma by ultra high-performance liquid chromatography-tandem mass spectrometry and its application to hepatic chemoembolization.
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DOI：
10.1016/j.jpba.2012.01.008
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发表时间：
2012-03-25
影响因子：
3.4
通讯作者：
Figg, William D.
中科院分区：
文献类型：
--
作者：
Chen, Xiaohong;Peer, Cody J.;Alfaro, Raul;Tian, Tian;Spencer, Shawn D.;Figg, William D.
开发并验证了一种分析方法，用于定量测定猪和人血浆中的伊立替康、其活性代谢物 SN38 和葡萄糖醛酸化 SN38 (SN38-G)。 SN38 和 SN38-G 的校准曲线在 0.5–100 ng/mL 的浓度范围内呈线性，伊立替康的校准曲线在 5–1000 ng/mL 的浓度范围内呈线性。样品预处理涉及 0.1 mL 等份血浆的固相萃取。使用由甲醇和 0.1% 甲酸组成的流动相，在 Waters ACQUITY UPLC™ BEH RP18 色谱柱（2.1×50 mm，1.7 µm）上分别分离伊立替康、SN38、SN38-G 和内标物伊立替康-d10、甲苯磺丁脲和喜树碱。伊立替康、SN38 和 SN38-G 的人血浆质量控制样品的准确度分别为 98.5-110.3%、99.5-101.7% 和 96.2-98.9%。同一顺序的三种分析物的精密度范围为 0.8-2.8%、2.4-5.7% 和 2.4-2.8%。事实证明，所有三种分析物在四个冷冻/解冻循环中在血浆中保持稳定，在室温下在全血中保持六个小时也保持稳定。该方法同样在猪血浆中进行了验证，其准确度和精密度也在普遍可接受的范围内。经验证的方法适用于涉及伊立替康药物洗脱珠肝化疗栓塞的临床前和临床试验，以研究三种分析物的药代动力学。
An analytical method was developed and validated for the quantitative determination of irinotecan, its active metabolite SN38, and glucuronidated SN38 (SN38-G) in both porcine and human plasma. Calibration curves were linear within the concentration range of 0.5–100 ng/mL for SN38 and SN38-G, and 5–1000 ng/mL for irinotecan. Sample pretreatment involved solid-phase extraction of 0.1 mL aliquots of plasma. Irinotecan, SN38, SN38-G, and the internal standards, irinotecan-d10, tolbutamide, and camptothecin, respectively, were separated on a Waters ACQUITY UPLC™ BEH RP18 column (2.1×50 mm, 1.7 µm), using a mobile phase composed of methanol and 0.1% formic acid. Accuracy of quality control samples in human plasma ranged from 98.5–110.3%, 99.5–101.7% and 96.2–98.9% for irinotecan, SN38, and SN38-G, respectively. Precision of the three analytes in the same order ranged from 0.8–2.8%, 2.4–5.7%, and 2.4–2.8%. All three analytes proved stable in plasma through four freeze/thaw cycles, as well as through six hours in whole blood at room temperature. The method was likewise validated in porcine plasma with comparable accuracies and precisions also within the generally acceptable range. The validated method was applied to both preclinical and clinical trials involving hepatic chemoembolization of irinotecan drug-eluting beads to study the pharmacokinetics of the three analytes.
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DOI：
10.1016/s0378-4347(99)00452-1
发表时间：
1999-12-24
期刊：
JOURNAL OF CHROMATOGRAPHY B
影响因子：
--
作者：
Ragot, S;Marquet, P;Lachâtre, G
通讯作者：
Lachâtre, G
影响因子：
1.8
作者：
Sai, K;Kaniwa, N;Sawada, J
通讯作者：
Sawada, J
影响因子：
2.9
作者：
de Bruijn, P;de Jonge, MJA;Sparreboom, A
通讯作者：
Sparreboom, A
DOI：
10.1016/s0378-4347(98)00554-4
发表时间：
1999-03-19
期刊：
JOURNAL OF CHROMATOGRAPHY B
影响因子：
--
作者：
Kurita, A;Kaneda, N
通讯作者：
Kaneda, N
DOI：
10.1016/s0378-4347(98)00270-9
发表时间：
1998-10-23
期刊：
JOURNAL OF CHROMATOGRAPHY B
影响因子：
--
作者：
Chollet, DF;Goumaz, L;Mazzo, DJ
通讯作者：
Mazzo, DJ