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- W2347184324 endingPage "2080" @default.
- W2347184324 startingPage "2073" @default.
- W2347184324 abstract "目的 应用在线脱盐-高效液相色谱-离子阱-飞行时间质谱(2D-LC-IT-TOF/MS)法鉴定盐酸多西环素片在药典条件下检出的有关物质结构,并推断盐酸多西环素在溶液状态下的降解途径。方法 LC 1stD色谱条件:InertSustainTM C18(4.6 mm×150 mm,5 μm)色谱柱,醋酸盐缓冲液[0.25 mol·L^-1醋酸铵-0.1 mol·L^-1 EDTA钠盐-三乙胺(100∶10∶1),用醋酸或氨水调节pH值至8.8]-乙腈(85∶15)为流动相进行等度洗脱;LC 2ndD 色谱条件:InertSustainTM C18(2.1 mm×50 mm,2 μm)色谱柱,0.1%甲酸-水溶液为流动相A,0.1%甲酸-乙腈为流动相B,进行梯度洗脱;质谱条件:ESI正负离子同时检测,雾化气流速1.5 L· min^-1,干燥气流速10 L· min^-1,脱溶剂管温度200 ℃。根据多级质谱信息来推定药典条件下检出的有关物质结构和强制降解溶液中产生的杂质结构。结果 在盐酸多西环素片中共检出8个有关物质,推定出其中4个含量大于0.1%的有关物质的结构,分别为4-表多西环素、美他环素、β-多西环素、2-乙酰-6-脱碳酰胺多西环素。盐酸多西环素溶液在碱性条件下易降解,生成脱酮基开环物;在高温条件下,容易产生4-表多西环素,并伴有少量4-表-6-表多西环素的生成;在酸性条件和光照条件下相对稳定。结论 建立的方法可用于盐酸多西环素中杂质的鉴定,为盐酸多西环素的质量控制与工艺优化研究提供可靠的分析手段。" @default.
- W2347184324 created "2016-06-24" @default.
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- W2347184324 date "2015-01-01" @default.
- W2347184324 modified "2023-09-24" @default.
- W2347184324 title "在线脱盐-高效液相色谱-离子阱-飞行时间质谱法鉴定盐酸多西环素有关物质结构" @default.
- W2347184324 hasPublicationYear "2015" @default.
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