| 引用本文: | 张金钟,仲婕,朱德领,李保山,施明珠,金艳,殷爱军.氢化黄原素的质量标准研究[J].中国现代应用药学,2013,30(3):299-302. |
| ZHANG Jinzhong,ZHONG Jie ,ZHU Deling,LI Baoshan,SHI Mingzhu,JIN Yan,YIN Aijun.Study on Quality Standard for Xanthane Hydride[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(3):299-302. |
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| 摘要: |
| 目的 建立氢化黄原素质量标准。方法 采用高效液相色谱法(HPLC)测定纯度，采用薄层色谱法(TLC)进行鉴别；并对干燥失重和灼烧残渣进行限度控制。结果 氢化黄原素的TLC斑点清晰，专属性强；HPLC主峰与相邻杂质分离度>1.5，主峰的重现性、日内精密度分别为0.72%，1.04%；干燥失重不超过3%，灼烧残渣不超过0.5%。结论 所建立的方法专属性好，操作方便，重现性好，结果可靠，可用于氢化黄原素的质量控制。 |
| 关键词: 氢化黄原素 质量标准 纯度测定 鉴别方法 |
| DOI： |
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| 基金项目:“十二五”国家重大新药创制科技重大专项(2011ZX09102-001-07、2011ZX09102-009-09) |
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| Study on Quality Standard for Xanthane Hydride |
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ZHANG Jinzhong, ZHONG Jie , ZHU Deling, LI Baoshan, SHI Mingzhu, JIN Yan, YIN Aijun
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Hangzhoutianlong Pharmaceutinal Co. Ltd., Hangzhou 310021, China
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| Abstract: |
| OBJECTIVE To establish the quality standards for xanthane hydride. METHODS The xanthane hydride was identified by thin layer chromatography(TLC), and its purity was determined by HPLC. RESULTS The TLC spots were clear and specific. The HPLC method results showed that, the degree of the separation between xanthane hydride and the next impurity was >1.5. The precision and repeatability were 0.72% and 1.04%, respectively. The loss on drying was less than 3% and the residue on ignition was lower than 0.5%. CONCLUSION A quick, easy and accurate method was established and used in the process of oligonucleotides synthesis. |
| Key words: xanthane hydride quality standards purity determination identification |
