Article(id=1322246468447097686, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246421869346895, articleNumber=null, orderNo=null, doi=null, 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=1606752000000, acceptedDateStr=2020-12-01, onlineDate=1793177724228, onlineDateStr=2026-10-28, pubDate=1624982400000, pubDateStr=2021-06-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177724228, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177724228, creator=13701087609, updateTime=1793177724228, updator=13701087609, issue=Issue{id=1322246421869346895, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='12', pageStart='1057', pageEnd='1152', issueExtLink='null', onlineDate='null', pubDate='1624982400000', pubDateStr='2021-06-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793177713123, creator='13701087609', updateTime=1793178158604, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322248290402414824, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246421869346895, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322248290402414825, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246421869346895, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1126, endPage=1131, ext={EN=ArticleExt(id=1322246468635841367, articleId=1322246468447097686, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Determination of mannitol in somatostatin for injection by HPLC-CAD, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To establish an HPLC-CAD method for determination of mannitol in somatostatin for injection.
Methods: Mannitol was determined by HPLC-CAD with Agilent 300Extend-C18 column (250 mm×4.6 mm, 5 μm), the mobile phase was acetonitrile-water (15∶85) at the flow rate of 1.0 mL·min-1, the column temperature was 35 ℃, and the injection volume was 20 μL. Charged aerosol detector (CAD) was used as detector, the evaporate tube temperature was 50 ℃, nebulizer gas was nitrogen, the flow pressure was about 60 psi, and the gain value was 1.
Results: The detection limit for mannitol was 1.004 μg·mL-1, and the limit of quantitation was 3.012 μg·mL-1. The quadratic curves showed good linearity in the range of 0.1~1.0 mg·mL-1(r2=0.999 8). The average recovery was 99.1% (RSD=0.60%).
Conclusion: This method is simple, rapid, sensitive, accurate and suitable for the quality control of mannitol in somatostatin for injection.
, authors=Wei ZHANG, Hui ZHANG, Jing LI, Yue SUN, Yi LI, Cheng-gang LIANG, authorsList=Wei ZHANG, Hui ZHANG, Jing LI, Yue SUN, Yi LI, Cheng-gang LIANG, authorCompany=null, correspAuthors=Hui ZHANG, Cheng-gang LIANG, 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=1322246468996551513, articleId=1322246468447097686, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=HPLC-CAD法测定注射用生长抑素中甘露醇的含量, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的： 研究并建立HPLC-CAD法测定注射用生长抑素中甘露醇的含量。
方法： 采用Agilent 300Extend-C18色谱柱（250 mm×4.6 mm，5 μm），流动相为乙腈-水（15∶85），流速1.0 mL·min-1，柱温35 ℃，进样量20 μL；检测器为CAD，雾化气体为氮气，蒸发管温度50 ℃，增益值1，气流压力为60 psi。
结果： 甘露醇的检测限为1.004 μg·mL-1，定量限为3.012 μg·mL-1，二次拟合范围为0.1~1.0 mg·mL-1（R2=0.999 8），平均回收率（n=9）为99.1%（RSD=0.60%）。
结论： 该方法简单、快速、灵敏、准确，可对注射用生长抑素中甘露醇进行质量控制。
, authors=张伟, 张慧, 李晶, 孙悦, 李懿, 梁成罡, authorsList=张伟, 张慧, 李晶, 孙悦, 李懿, 梁成罡, authorCompany=null, correspAuthors=张慧, 梁成罡, authorNote=
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张伟，男，副主任药师，主要从事化药、生化药以及重组激素类药物质量控制研究。联系电话：（010）53851619，E-mail：maximer325@163.com。
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张伟，男，副主任药师，主要从事化药、生化药以及重组激素类药物质量控制研究。联系电话：（010）53851619，E-mail：maximer325@163.com。
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