Article(id=1309634583109398541, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634582362809158, articleNumber=null, orderNo=null, doi=10.12048/j.issn.1674-229X.2026.04.006, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1767801600000, receivedDateStr=2026-01-08, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1790170816447, onlineDateStr=2026-09-23, pubDate=1777046400000, pubDateStr=2026-04-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1790170816447, onlineIssueDateStr=2026-09-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1790170816447, creator=13701087609, updateTime=1790170816447, updator=13701087609, issue=Issue{id=1309634582362809158, tenantId=1146029695717560320, journalId=1227999776411738115, year='2026', volume='36', issue='4', pageStart='241', pageEnd='320', issueExtLink='null', onlineDate='null', pubDate='1777046400000', pubDateStr='2026-04-25', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1790170816268, creator='13701087609', updateTime=1790219015105, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1309836742979576497, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634582362809158, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1309836742979576498, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634582362809158, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=282, endPage=285, ext={EN=ArticleExt(id=1309634583298142222, articleId=1309634583109398541, tenantId=1146029695717560320, journalId=1227999776411738115, language=EN, title=Simultaneous Determination of Three Impurities in Trihexyphenidyl Hydrochloride Tablets by GC-MS, columnId=null, journalTitle=Pharmacy Today, columnName=null, runingTitle=null, highlight=null, articleAbstract=
OBJECTIVE

To develop a gas chromatography-mass spectrometry (GC-MS) method for the determination of cyclohexane and potential genotoxic impurities (chlorocyclohexane and 1-cyclohexyl-1-phenylethanol) in trihexyphenidyl hydrochloride tablets.

METHODS

The VF-WAXms capillary column (30 m × 0.25 mm, 1.00 μm) was used. High-purity helium was used as the carrier gas at a flow rate of 2.0 mL·min-1, with a split ratio of 5∶1 and an injection volume of 2 μL. The mass spectrometer was equipped with an electron ionization (EI) source and operated in the selected ion monitoring (SIM) mode for detection.

RESULTS

The results showed that chlorocyclohexane, cyclohexanol, and 1-cyclohexyl-1-phenylethanol exhibited good linear relationships in the range of 25-250 ng·mL-1, with detection limits (LOD) of 10.2, 10.0 and 9.8 ng·mL-1, and quantification limits (LOQ) of 25.4, 25.0 and 24.5 ng·mL-1, respectively. The average recovery rates (n = 6) were 98.93%, 102.93% and 99.97%, respectively.

CONCLUSION

The established method has good specificity and high sensitivity, and can serve as a reference for the quality control of trihexyphenidyl hydrochloride tablets.

, authors=Kang SHI1, Xueyan CHEN2, Junliang DUAN3, Fengyun PAN3, Wenzhi WEI2, *, authorsList=Kang SHI, Xueyan CHEN, Junliang DUAN, Fengyun PAN, Wenzhi WEI, authorCompany=null, correspAuthors=Wenzhi WEI, 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=1309634583608520719, articleId=1309634583109398541, tenantId=1146029695717560320, journalId=1227999776411738115, language=CN, title=GC-MS法同时测定盐酸苯海索片中3种杂质, columnId=1228268589086606089, journalTitle=今日药学, columnName=论著, runingTitle=null, highlight=null, articleAbstract=
目的

建立了气相色谱-质谱法(GC-MS)测定盐酸苯海索片中环己烷和潜在基因毒性杂质氯代环己烷、1-环己基-1-苯乙醇。

方法

采用VF-WAXms毛细管柱(30 m × 0.25 mm,1.00 μm),载气为高纯氦气,流速为2.0 mL·min-1,分流比5:1,进样量2 μL;质谱检测器的离子源采用电子轰击(EI)离子源,选择离子检测(SIM)模式进行测定。

结果

氯代环己烷、环己醇和1-环己基-1-苯乙醇在25 ~ 250 ng·mL-1范围内线性关系良好,检测限分别为10.2、10.0、9.8 ng·mL-1,定量限分别为25.4、25.0、24.5 ng·mL-1,平均回收率分别为98.93%、102.93%、99.97%。

结论

所建立的方法专属性好,灵敏度高,可以为盐酸苯海索片的质量控制提供参考。

, authors=史康1, 陈学艳2, 段军良3, 潘峰云3, 魏文芝2, *, authorsList=史康, 陈学艳, 段军良, 潘峰云, 魏文芝, authorCompany=null, correspAuthors=魏文芝, authorNote=

史康,硕士研究生,研究方向:药物分析与药品质量标准制订

, correspAuthorsNote=

*

魏文芝,硕士,主任药师,研究方向:药品质量分析、药品质量标准研究,E-mail:
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GC-MS法同时测定盐酸苯海索片中3种杂质
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史康 1 , 陈学艳 2 , 段军良 3 , 潘峰云 3 , 魏文芝 2, *
今日药学 | 论著 2026,36(4): 282-285
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今日药学 |论著 2026 , 36 (4) : 282 -285
GC-MS法同时测定盐酸苯海索片中3种杂质
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史康1, 陈学艳2, 段军良3, 潘峰云3, 魏文芝2, *
作者信息
  • 1.青海民族大学药学院,青海 西宁 810016
  • 2.青海省药品检验检测院/国家药品监督管理局中药(藏药)质量控制重点实验室/青海省中藏药现代化研究重点实验室,青海 西宁 810016
  • 3.中科谱研(北京)科技有限公司,北京 100096
通讯作者:

*

魏文芝,硕士,主任药师,研究方向:药品质量分析、药品质量标准研究,E-mail:
作者简介:

史康,硕士研究生,研究方向:药物分析与药品质量标准制订

Simultaneous Determination of Three Impurities in Trihexyphenidyl Hydrochloride Tablets by GC-MS
Kang SHI1, Xueyan CHEN2, Junliang DUAN3, Fengyun PAN3, Wenzhi WEI2, *
Affiliations
  • 1.School of Pharmacy, Qinghai Minzu University, Xining, Qinghai 810016, China
  • 2.Qinghai Provincial Drug Inspection and Testing Institute/NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine (Tibetan Medicine)/Qinghai Provincial Key Laboratory of Modernization of Traditional Chinese and Tibetan Medicine, Xining, Qinghai 810016, China
  • 3.Zhongke Puyan (Beijing) Technology, Beijing 100096, China
出版时间: 2026-04-25 doi: 10.12048/j.issn.1674-229X.2026.04.006
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目的

建立了气相色谱-质谱法(GC-MS)测定盐酸苯海索片中环己烷和潜在基因毒性杂质氯代环己烷、1-环己基-1-苯乙醇。

方法

采用VF-WAXms毛细管柱(30 m × 0.25 mm,1.00 μm),载气为高纯氦气,流速为2.0 mL·min-1,分流比5:1,进样量2 μL;质谱检测器的离子源采用电子轰击(EI)离子源,选择离子检测(SIM)模式进行测定。

结果

氯代环己烷、环己醇和1-环己基-1-苯乙醇在25 ~ 250 ng·mL-1范围内线性关系良好,检测限分别为10.2、10.0、9.8 ng·mL-1,定量限分别为25.4、25.0、24.5 ng·mL-1,平均回收率分别为98.93%、102.93%、99.97%。

结论

所建立的方法专属性好,灵敏度高,可以为盐酸苯海索片的质量控制提供参考。

气相色谱-质谱  /  盐酸苯海索  /  氯代环己烷  /  环己醇  /  1-环己基-1-苯乙醇
OBJECTIVE

To develop a gas chromatography-mass spectrometry (GC-MS) method for the determination of cyclohexane and potential genotoxic impurities (chlorocyclohexane and 1-cyclohexyl-1-phenylethanol) in trihexyphenidyl hydrochloride tablets.

METHODS

The VF-WAXms capillary column (30 m × 0.25 mm, 1.00 μm) was used. High-purity helium was used as the carrier gas at a flow rate of 2.0 mL·min-1, with a split ratio of 5∶1 and an injection volume of 2 μL. The mass spectrometer was equipped with an electron ionization (EI) source and operated in the selected ion monitoring (SIM) mode for detection.

RESULTS

The results showed that chlorocyclohexane, cyclohexanol, and 1-cyclohexyl-1-phenylethanol exhibited good linear relationships in the range of 25-250 ng·mL-1, with detection limits (LOD) of 10.2, 10.0 and 9.8 ng·mL-1, and quantification limits (LOQ) of 25.4, 25.0 and 24.5 ng·mL-1, respectively. The average recovery rates (n = 6) were 98.93%, 102.93% and 99.97%, respectively.

CONCLUSION

The established method has good specificity and high sensitivity, and can serve as a reference for the quality control of trihexyphenidyl hydrochloride tablets.

GC-MS  /  trihexyphenidyl hydrochloride  /  chlorocyclohexane  /  cyclohexanol  /  1-cyclohexyl-1-phenylethanol
史康, 陈学艳, 段军良, 潘峰云, 魏文芝. GC-MS法同时测定盐酸苯海索片中3种杂质. 今日药学, 2026 , 36 (4) : 282 -285 . DOI: 10.12048/j.issn.1674-229X.2026.04.006
Kang SHI, Xueyan CHEN, Junliang DUAN, Fengyun PAN, Wenzhi WEI. Simultaneous Determination of Three Impurities in Trihexyphenidyl Hydrochloride Tablets by GC-MS[J]. Pharmacy Today, 2026 , 36 (4) : 282 -285 . DOI: 10.12048/j.issn.1674-229X.2026.04.006
  • 2023年国家药品抽检计划
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doi: 10.12048/j.issn.1674-229X.2026.04.006
  • 接收时间:2026-01-08
  • 首发时间:2026-09-23
  • 出版时间:2026-04-25
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  • 收稿日期:2026-01-08
基金
2023年国家药品抽检计划
作者信息
    1.青海民族大学药学院,青海 西宁 810016
    2.青海省药品检验检测院/国家药品监督管理局中药(藏药)质量控制重点实验室/青海省中藏药现代化研究重点实验室,青海 西宁 810016
    3.中科谱研(北京)科技有限公司,北京 100096

通讯作者:

*

魏文芝,硕士,主任药师,研究方向:药品质量分析、药品质量标准研究,E-mail:
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2种不同金属材料的力学参数
科
Family
属数
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genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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