张新勇,葛雪松,孙桐,等.超高效液相色谱串联三重四极杆质谱法测定三种葡萄糖制剂中 5-羟甲基糠醛的含量[J].安徽医药,2023,27(4):679-682. |
超高效液相色谱串联三重四极杆质谱法测定三种葡萄糖制剂中 5-羟甲基糠醛的含量 |
Determination of 5-Hydroxymethyl furfural in three glucose preparations by UPLC-MS/MS |
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DOI:10.3969/j.issn.1009-6469.2023.04.010 |
中文关键词: 葡萄糖 药物污染 超高效液相色谱串联三重四极杆质谱(UPLC-MS/MS) 5-羟甲基糠醛 质量控制 |
英文关键词: Glucose Drug contamination UPLC-MS/MS 5-HMF Quality control |
基金项目: |
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中文摘要: |
目的建立葡萄糖注射液、葡萄糖酸钙口服溶液与盐酸氨基葡萄糖胶囊中 5-羟甲基糠醛的超高效液相色谱串联三重四极杆质谱测定方法。方法 2021年 1—9月,采用 ACQUITY UPLC HSS T3(2.1 mm×100 mm,1.8 μm)色谱柱,流动相为 0.05%甲酸溶液 -甲醇( 85∶15),流速为 0.3 mL/min,柱温 30 ℃,进样盘温度 5℃,进样体积 2 μL。质谱条件: ESI源,正离子扫描,脱溶剂温度: 400 ℃;干燥气流速: 15 L/min;毛细管电压: 3.0 kV。结果 5-羟甲基糠在 2.07~155.25 μg/L浓度范围内,线性关系良好( r=0.999 7)定量限为 0.36 μg/L,平均回收率为 99.54%,RSD为 1.63%(n=9)。结论该方法专属性较强,灵敏度高,稳定性 |
英文摘要: |
Objective To establish an UPLC-MS/MS method for determination of 5-Hydroxymethylfurfural (5-HMF) in Glucose Injection, Calcium Gluconate Oral Solution and Glucosamine Hydrochloride Capsules.Method From January 2021 to September 2021,an ACQUITY UPLC HSS T3 (2.1 mm×100 mm, 1.8 μm) was used, the mobile phase was 0.05% formic acid solution-methanol (85∶15),the flow rate was 0.3 mL/min, the column temperature was 30 ℃ and the sample plate temperature was 5 ℃, the sample volume was 2μL. MS conditions: ESI ion source was used and positive ion scanning; the desolvation temperature was 400 ℃, the dry gas flow ratewas 15 L/min and the capillary voltage was 3.0 kV.Result There was a good linear relationship within the range of 2.07-155.25 μg/L for 5-HMF (r=0.999 7), and the limit of quantitation of 0.36 μg/L, the average recovery of 99.54% with RSD of 1.63% (n=9).Conclu? sion The method shows promising specificity, high sensitivity and good stability, can be used in the quality control of 5-HMF in three preparations. |
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