Article(id=1291704893706887516, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.19.016, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1747152000000, receivedDateStr=2025-05-14, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896045375, onlineDateStr=2026-08-05, pubDate=1760630400000, pubDateStr=2025-10-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896045375, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896045375, creator=13701087609, updateTime=1785896045375, updator=13701087609, issue=Issue{id=1291704892859638107, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='19', pageStart='2701', pageEnd='2850', issueExtLink='null', onlineDate='null', pubDate='1760630400000', pubDateStr='2025-10-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896045171, creator='13701087609', updateTime=1785896787712, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291708007352656266, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291708007352656267, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2805, endPage=2809, ext={EN=ArticleExt(id=1291704893950157149, articleId=1291704893706887516, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Determination of busulfan concentration in plasma of hematopoietic stem cell transplantation patients by LC-MS/MS, columnId=1246531413395263850, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Research Method, runingTitle=null, highlight=null, articleAbstract=
Objective To establish a liquid chromatography tandem mass spectrometry (LC-MS/MS) method for determine the concentration of busulfan in plasma of hematopoietic stem cell transplantation (HSCT) patients and apply it to clinical sample detection.
Method A Symmetry C18 column 150.0 mm ( 4.6 mm, 3.5 μm) was used. The mobile phase consisted of phase A (10 mmol·L-1 ammonium formate solution, containing 0.1% formic acid, v/v) and phase B (acetonitrile), and was subjected to gradient elution at a flow rate of 0.8 mL·min-1, and the injection volume was 10 μL. The internal standard was carbamazepine. The quantitative analysis was ionized with atmospheric pressure chemical ionization source (APCI), positive ion mode, and multi reaction monitoring (MRM). Detecting ion pairs were busulfan 264.4→151.2, carbamazepine 237.1→194.0. The specificity, standard curve, precision, recovery rate, matrix effect and stability of the method were validated.
Result The retention times of busulfan and internal standard were 5.1 min and 5.3 min, respectively. The standard curve equation for busulfan in plasma was y=0.06x-0.04 (r=0.998 7), with a linear range of 0.1-10.0 μg·mL-1. The relative standard deviation (RSD) of intra-day and inter-day precision were less than 10%; The recovery rate was 95.64%-104.49%, and the matrix effect was 100.11%-118.87%. The RSD of the stability of quality control samples after low-temperature storage, three freeze-thaw cycles, or room temperature storage were less than 10%. The average drug exposure of patients undergoing HSCT was (4.99±2.76) μg·mL-1·h (range 0.66-13.77 μg·mL-1·h).
Conclusion The established LC-MS/MS method has short analysis time, good specificity, and high precision, and is suitable for the therapeutic drug monitoring of busulfan in HSCT patients.
, authors=Xi-kun WU, Jing-pu XU, Ying WANG, Fu-xu WANG, Zhi-qing ZHANG, authorsList=Xi-kun WU, Jing-pu XU, Ying WANG, Fu-xu WANG, Zhi-qing ZHANG, authorCompany=null, correspAuthors=Zhi-qing ZHANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291704894415724894, articleId=1291704893706887516, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=用LC-MS/MS法测定造血干细胞移植患者血浆中白消安的浓度, columnId=1246531413600784769, journalTitle=中国临床药理学杂志, columnName=研究方法, runingTitle=null, highlight=null, articleAbstract=
目的 建立测定造血干细胞移植（HSCT）患者血浆中白消安浓度的液相色谱-串联质谱联用（LC-MS/MS）检测方法，并应用于临床标本检测。
方法 色谱柱为Symmetry C18色谱柱150.0 mm（4.6 mm，3.5 μm）；流动相A为10 mmol·L-1甲酸铵溶液（含0.1%甲酸，v/v），流动相B为乙腈；梯度洗脱，流速0.8 mL·min-1；进样量10 μL；内标为卡马西平。用大气压化学电离源（APCI），阳离子模式，多反应监测（MRM）方式进行检测。检测离子对为白消安264.4→151.2，卡马西平237.1→194.0。对方法的专属性、标准曲线和定量下限、精密度和回收率、基质效应及稳定性进行验证。
结果 白消安和内标的保留时间分别为5.1 min和5.3 min，血浆中白消安的标准曲线方程为y=0.06x-0.04（r=0.998 7），线性范围0.1~10.0 μg·mL-1。日内和日间精密度的相对标准偏差（RSD）均<10%；回收率为95.64%~104.49%，基质效应为100.11%~118.87%。白消安质控样本低温保存、冻融循环3次或室温放置稳定性的RSD均<10%。HSCT患者平均药物暴露为（4.99±2.76）μg·mL-1·h（范围：0.66~13.77 μg·mL-1·h）。
结论 所建立LC-MS/MS方法分析时间短、专属性好、精密度高，适用于临床HSCT患者白消安的治疗药物监测。
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武玺坤（1991-），男，主管药师，主要从事药代动力学、治疗药物监测方面的研究
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