| 毛细管电泳法测定舒必利异构体 |
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| 引用本文： | 杨锐,韩旭,袁松,于丽娜,孙会敏,刘靖新. 毛细管电泳法测定舒必利异构体[J]. 药物分析杂志, 2012, 0(8): 1422-1424,1421 |
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| 作者姓名： | 杨锐 韩旭 袁松 于丽娜 孙会敏 刘靖新 |
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| 作者单位： | 中国食品药品检定研究院;北京托毕西制药有限公司;北京大学化学院 |
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| 摘 要： | 目的:建立分离舒必利消旋体并准确检测左舒必利片剂中主药含量的毛细管电泳法。方法:采用熔融石英毛细管柱(50μm×31 cm,有效长度为21 cm),以含2%高磺化α-环糊精的20 mmol.L-1柠檬酸钠缓冲溶液为运行缓冲液,检测波长为214 nm,分离电压为-10 kV。结果:实现了左舒必利和右舒必利的基线分离,左舒必利在0.001～0.1 mg.mL-1范围内线形关系良好,用建立的方法检测3批左舒必利片标示含量分别为97.08%,98.77%,98.78%。结论:本方法灵敏度高,简便快捷,适用于左舒必利片剂的含量测定和质量控制。
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| 关 键 词： | 毛细管电泳 左舒必利 右舒必利 高磺化α-环糊精 手性分离试剂 异构体测定 |
Capillary electrophoresis determination of sulpiride enantiomers |
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| Affiliation: | YANG Rui1,HAN Xu2,YUAN Song1,YU Li-na1, SUN Hui-min1 ,LIU Jin-xin3(1.National Institutes for Food and Drug Control,Beijing 100050,China;2.Beijing Tobishi Pharmaceutical Co.,Ltd,Beijing 100036,China; 3.College of Chemistry and Molecular Engineering,Peking University,Beijing 100871,China) |
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| Abstract: | Objective:To develop a method for chiral separation of sulpiride enantiomers and determination of the levosulpiride content in tablets by capillary electrophoresis.Method:Fused silica capillary column(50 μm×31 cm,21 cm of effective length) was adopted,and 20 mmol·L-1 citrate buffer solution containing 2% high sulfated-α-cyclodextrins was used as running buffer.The detection wavelength was set at 214 nm.The separation voltage was-10 kV.Results:Baseline separation of levosulpiride and dextrosulpiride was achieved.The linearity was excellent in the concentration ranged from 0.001-0.1 mg·mL-1 for levosulpiride.The labeled contents of levosulpiride in samples were 97.08%,98.77%,and 98.78%,respectively.Conclusion:The established method is convenient and with high sensitivity,which can be applied for quality control of sulpiride tablets. |
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| Keywords: | capillary electrophoresis levosulpiride dextrosulpiride high sulfated α-cyclodextrins chiral separation reagent enantiomers assay |
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