Article(id=1321425675249107341, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.09.010, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1757520000000, acceptedDateStr=2025-09-11, onlineDate=1792982031881, onlineDateStr=2026-10-26, pubDate=1778774400000, pubDateStr=2026-05-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982031881, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982031881, creator=13701087609, updateTime=1792982031881, updator=13701087609, issue=Issue{id=1321425625915707977, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='9', pageStart='897', pageEnd='1008', issueExtLink='null', onlineDate='null', pubDate='1778774400000', pubDateStr='2026-05-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982020119, creator='13701087609', updateTime=1792983090252, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321430114441745406, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321430114441745407, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=969, endPage=976, ext={EN=ArticleExt(id=1321425675488182670, articleId=1321425675249107341, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Chiral separation and detection of three optical isomers in palonosetron hydrochloride by supercritical fluid chromatography with two columns in series, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To establish a supercritical fluid chromatography (SFC) method for the determination of chiral purity of palonosetron hydrochloride using two columns in series, and to determine the isomers in palonosetron hydrochloride bulk drug and injections.
Methods: Two columns, DAICEL CHIRALPAK AD-3 (150 mm×3.0 mm, SFC, 3 μm) and DAICEL CHIRALPAK IG-3 (150 mm×3.0 mm, SFC, 3 μm), were in series. The column temperature was at 37 ℃, the mobile phase was composed of CO2 and a mixture of anhydrous ethanol, acetonitrile, and diethylamine at a ratio of 55∶45, the back pressure was at 12 MPa, the flow rate was 1.2 mL·min-1, the injection volume was 20 μL, and the detection wavelength was at 240 nm.
Results: The R,S isomer, R,R enantiomer, S,R isomer, and palonosetron were eluted sequentially within 10 min with resolutions of 1.7, 2.3, and 1.5, respectively. All four compounds exhibited good linearity between peak area and concentration in the range from 0.20 to 10.0 μg·mL-1, with r all greater than 0.999 5. The detection limits (S/N=3) of the three isomers were all 0.10 μg·mL-1; and the quantitation limits (S/N=10) were all 0.20 μg·mL-1. The average recoveries of the three isomers in the bulk drug and injections ranged from 97.8% to 101.3%, with relative standard deviations (RSDs) ranged from 0.3% to 1.5% (n=9). Except for one batch of bulk drug in which no chiral impurity was detected, the R,S isomer was detected in all the other five batches, with contents ranging from 0.03% to 0.12%.
Conclusion: The developed SFC method can separate palonosetron and its three isomers in a short analysis time, and the use of two columns in series improves the separation efficiency, especially the resolution between the S,R isomer and palonosetron. The method is accurate, reliable, and can be used as an effective means for chiral purity determination and quality control of palonosetron hydrochloride bulk drug and related preparations.
, authors=Xiang-hui MENG
1, Jia-bei SUN
1, Yu WANG
2, Shang-chen YAO
1, *, authorsList=Xiang-hui MENG, Jia-bei SUN, Yu WANG, Shang-chen YAO, authorCompany=null, correspAuthors=Shang-chen YAO, 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=1321425675895030159, articleId=1321425675249107341, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=双柱串联超临界流体色谱法拆分盐酸帕洛诺司琼及3个光学异构体, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的： 建立双柱串联方式测定盐酸帕洛诺司琼手性纯度的超临界流体色谱方法（SFC），同时测定原料及注射液中光学异构体的含量。
方法： 采用2根手性色谱柱DAICEL CHIRALPAK AD-3色谱柱（150 mm×3.0 mm SFC, 3 μm）和DAICEL CHIRALPAK IG-3色谱柱（150 mm×3.0 mm SFC, 3 μm）串联的方式，柱温为37 ℃，以超临界CO2-[无水乙醇∶乙腈∶二乙胺（70∶30∶1）]混合溶液（55∶45）作为流动相，背压为12 MPa，进样量为20 μL，流速为1.2 mL·min-1，检测波长为240 nm。
结果： R,S异构体、R,R对映异构体、S,R异构体和帕洛诺司琼可在10 min内依次洗脱并完全分离，各峰之间的分离度分别为1.7、2.3和1.5；各组分在0.20~10.0 μg·mL-1浓度范围内线性良好，r均大于0.999 5。3个异构体的检测限均为0.10 μg·mL-1（S/N=3），定量限均为0.20 μg·mL-1（S/N=10）；盐酸帕洛诺司琼原料及注射液中3个光学异构体的平均加样回收率范围为97.8%~101.3%，RSD范围为0.3%~1.5%（n=9）。除1批原料中未检出手性杂质外，其余5批样品中均检出了R,S异构体，含量范围为0.03%~0.12%。
结论： 利用SFC法可显著缩短帕洛诺司琼手性拆分的分析时间，采用双柱串联后，可改善分离效果，尤其是S,R异构体与帕洛诺司琼之间的分离度得到有效提高。本方法准确可靠，可作为盐酸帕洛诺司琼原料及相关制剂中手性纯度测定和质量控制的有效手段。
, authors=孟祥慧
1, 孙葭北
1, 王渔
2, 姚尚辰
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孟祥慧，女，博士研究生，主要从事化学药品质量控制、药效及毒理学评价研究。E-mail: mengxianghui@nifdc.org.cn。
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