Article(id=1236334088014066352, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236334083500995077, 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=1679587200000, acceptedDateStr=2023-03-24, onlineDate=1772694616558, onlineDateStr=2026-03-05, pubDate=1690646400000, pubDateStr=2023-07-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772694616558, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772694616558, creator=13701087609, updateTime=1772694616558, updator=13701087609, issue=Issue{id=1236334083500995077, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='14', pageStart='1385', pageEnd='1488', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=0, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772694615483, creator=13701087609, updateTime=1772696065206, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236340164130295845, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236334083500995077, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236340164130295846, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236334083500995077, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1478, endPage=1481, ext={EN=ArticleExt(id=1236334088240558779, articleId=1236334088014066352, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Determination of noracetildenafil by
1H qNMR, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To establish an 1H quantitative nuclear magnetic resonance (1H qNMR) method for determination of noracetildenafil.
Methods: 1H qNMR spectra were obtained in CDCL3 by using Bruker Ascend 600 spectrometer with noesyigld1d pulse sequence, the relaxation delay time was 30 s, and 32 scans were recorded.
Results: The signals δ8.15 and 9.14 of noracetildenafil and δ6.09 of 1,3,5-Trimethoxybenzene were used for quantitation. Linear regression of areas ratio (As/Ar) versus mass ratio (Ws/Wr) of δ8.15 and 6.09 yielded a correlation coefficient of 0.999 1 and regression equation of y=0.119 7x+0.003 4, the replicability RSD was 1.66% (n=5), the repeatability RSD was 0.76% (n=5), and the determined content was 97.48%. Linear regression of areas ratio (As/Ar) versus mass ratio (Ws/Wr) at δ9.14 and 6.09 yielded a correlation coefficient of 0.999 1 and regression equation of y=0.116 8x+0.004 5, the replicability RSD was 1.69% (n=5), the repeatability RSD was 0.43% (n=5), and the content of noracetildenafil was 95.35%. The result determined by 1H qNMR method (96.42%) was consistent with the results by mass balance method (96.54%) and HPLC assay method (97.07%).
Conclusion: The established 1H qNMR method can be used for the quantitative determination of noracetildenafil. It is accurate and rapid and could be complementary with the mass balance method for the assay of reference substances.
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1H定量核磁共振波谱法测定那红地那非的含量, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的： 建立采用1H定量核磁共振（qNMR）波谱法测定那红地那非对照品的含量。
方法： 在 1H qNMR中，使用Bruker Ascend 600超导核磁共振谱仪，以氘代氯仿为溶剂，采用noesyigld1d脉冲序列，弛豫延迟时间为30 s，扫描次数32次。
结果： 以那红地那非δ8.15和δ9.14的氢质子响应信号作为样品定量信号，以1，3，5-三甲氧基苯δ6.09的氢质子响应信号作为内标物定量信号。样品δ8.15与内标物δ6.09信号响应面积比与质量比的线性回归方程为y=0.119 7x+0.003 4，相关系数为0.999 1，重现性实验的RSD为1.66%（n=5），重复性实验的RSD为0.76%，测得那红地那非的含量为97.48%；样品δ9.14与内标物δ6.09信号响应面积比与质量比的线性回归方程为：y=0.116 8x+0.004 5，相关系数为0.999 1，重现性实验的RSD为1.69%，重复性实验的RSD为0.43%，测得那红地那非的含量为95.35%。1H qNMR法测得那红地那非的含量（两组响应信号测得的含量平均值）为96.42%，与质量平衡法结果（96.54%）以及HPLC外标一点法结果（97.07%）一致。
结论： 本研究建立的核磁定量方法可用于那红地那非的含量测定，该方法准确、快速，并为质量平衡法对标准物质定值提供有力的佐证。
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冯玉飞，女，助理研究员，研究方向：药品质量控制和药品标准物质研究。联系电话：(010)67095510，E-mail: fengyf@nifdc.org.cn。
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冯玉飞，女，助理研究员，研究方向：药品质量控制和药品标准物质研究。联系电话：(010)67095510，E-mail: fengyf@nifdc.org.cn。
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黄海伟，男，副主任药师，研究方向：药品质量控制和标准物质研究。E-mail: huanghw@nifdc.org.cn。
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