| 靳贵英,王淼,王彩媚.离子色谱法测定药用辅料β-环糊精的有关物质[J].安徽医药,2017,21(8):1388-1390. |
| 离子色谱法测定药用辅料β-环糊精的有关物质 |
| Determination of related substances in pharmaceutical excipient β-cyclodextrin using ion chromatograph |
| 投稿时间：2017-02-13 |
| DOI： |
| 中文关键词: β-环糊精 有关物质 α-环糊精 γ-环糊精 离子色谱法 |
| 英文关键词: |
| 基金项目:广东省省级科技计划项目(2013B040200029)；2016年国家药品评价性抽验专项资助离子色谱法测定药用辅料β-环糊精的有关物质靳贵英,王淼,王彩媚 (广东省药品检验所辅料室,广东 广州 510180)◇药物分析◇ 离子色谱法测定药用辅料β-环糊精的有关物质 靳贵英,王淼,王彩媚 Determination of related substances in pharmaceutical excipient β-cyclodextrin using ion chromatograph JIN Guiying,WANG Miao,WANG Caimei |
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| 中文摘要: |
| 目的 建立测定β-环糊精中有关物质α-环糊精和γ-环糊精的离子色谱方法,并用质谱进行验证。方法 采用离子色谱法,CarPac PA 200离子柱,柱温30 ℃,安培检测器,金电极为工作电极,Ag/AgCl为参比电极。高分辨质谱法采用电喷雾电离模式,离子阱扫描范围为300～1 400。结果 α-环糊精和γ-环糊精的检出限为0.2和0.5 mg·L-1,定量限分别为0.4和1.0 mg·L-1。采用离子肼质谱法确认了α-环糊精和γ-环糊精,结果与离子色谱相一致。所有样品均检出γ-环糊精,同时探讨了其限量标准,为该品种标准提高和风险监控提供了技术参数。结论 该方法快速、有效,可用于β-环糊精中有关物质的检测。 |
| 英文摘要: |
| Objective To establish the ion chromatograph for the determination of related substances α-,γ-cyclodextrin in excipient β-cyclodextrin.Mass spectrometry is used to confirm impurity. Methods Using ion chromatograph with ionic columns of CarPac PA 200 at a column temperature of 30 ℃.Amperometric detector was used,while Au as work electrode and Ag/AgCl as reference electrode.A high resolution mass spectra is used with electrospray ionization mode.Ion trap scanning range is 300-1 400. Results The limits of detection of α-,γ-cyclodextrin were 0.2 and 0.5 mg·L-1,respectively.The limit of quantification of α-,γ-cyclodextrin were 0.4 and 1.0 mg·L-1,respectively.α-cyclodextrin and γ-cyclodextrin were confirmed by ion trap mass spectrometry.The results were consistent with those of ion chromatography.The study showed that all samples contain γ-cyclodextrin.In addition,the limitation of the related substances in the excipient was discussed.Those are the important technical parameters for the standard improvement and risk monitor. Conclusion This method is rapid and effective for the determination of related substance of β-cyclodextrin. |
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