| 张肖宁,刘云飞,杨利红.HPLC-TOF-MS分析盐酸羟苄唑原料有关物质[J].中国药品标准,2016,17(3):189-193 |
| HPLC-TOF-MS分析盐酸羟苄唑原料有关物质 |
| HPLC-TOF-MS Analysis on Hydrobenzole Hydrochloride Related Substances |
| 投稿时间：2016-01-12 修订日期：2016-04-29 |
| DOI： |
| 中文关键词: 盐酸羟苄唑 高效液相色谱 质谱 有关物质 |
| 英文关键词: Hydrobenzole Hydrochloride HPLC MS related substances |
| 基金项目: |
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| 摘要点击次数: 802 |
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| 中文摘要: |
| 目的：对盐酸羟苄唑原料中的有关物质进行分析，分析其杂质来源。方法: 采用HPLC-TOF-MS法。色谱柱 为Zorbax XDB C18(4.6 mm×150mm，5 μm)，流动相为甲醇-乙腈-醋酸铵缓冲液（pH4.0）（20:10:70），流量1.0ml?min-1，检测波长277nm；采用电喷雾离子源（ ESI），，离子源温度为120℃，， 正/负离子扫描检测，一级全扫描及二级扫描测定，质量扫描范围m/z100~1200。结果：初步分析有两个主要杂质,并推测其结构及来源。结论：本方法的分析结果，可为盐酸羟苄唑原料质量标准提高提供重要依据，并为其质量控制提供保障。 |
| 英文摘要: |
| Objective: To analyze the related substances of Hydrobenzole Hydrochloride and the source of impurity. Methods: An HPLC-TOF-MS method was adopted. The assay was performed on a Zorbax XDB C18 column (4.6 mm × 150mm, 5 μm)with a mobile phase of methanol - acetonitrile - ammonium acetate buffer (pH 4.0) (20:10:70)at a flow rate of 1.0ml ? min-1， the detection wavelength was 277nm. The full scan and two stage scanningwas employed for detection with ESI source in positive/negative ion mode. the source temperaturewas 120 ℃ ，， and mass scan range was m/z 100~1200. Results: Two main impurities were analyzed preliminarily, the structures and origins were speculated.Conclusion: The results of analysis can provide an important basis for improving the quality standards and protection for their quality control. |
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