高效液相色谱测定氯波必利片剂含量及其有关物质___
HPLC determination of clebopride tablets and its related substances
分类号：
出版年·卷·期（页码）：2009,29 (6):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
摘要 目的：建立高效液相色谱法测定氯波必利片剂的含量及有关物质。方法：采用Cosmosil Cl8色谱柱(4.6 mm×250 mm，5 μm) 流动相：以甲醇-水（60∶40，含20 mmol•L-1的醋酸-醋酸钠溶液，pH=4.5） 流速：1.0 mL•min-1 柱温：25 ℃ 检测波长：274 nm。结果：在所选定的液相色谱条件下，有关物质与主药分离良好，氯波必利在10~200 μg•mL-1范围内，线性关系良好，检出灵敏度为1.0 ng。结论：方法简便灵敏，结果准确可靠，可用于氯波必利片剂含量的测定及其杂质检查。
-----英文摘要：---------------------------------------------------------------------------------------
Abstract Objective:To eastablish an HPLC method for determination of clebopride tablets and its related substances.Methods:Cosmosil Cl8(4.6 mm×250 mm，5 μm),with the mobile phase consisted of methanol-water (60∶40,containing 20 mmol•L-1 acetic acid-sodium acetate solution,pH 4.5),the flow rate was 1.0 mL•min-1,the column temperature of 25 ℃,detection wavelength at 274 nm ， the injection volume was 20 μL and external standard method.Results:clebopride and its related substances can be completely separated by the method with a liner range of 10-200 μg•mL-1.A detection limit of 1.0 ng.Conclusion:The method is simple，sensitive，accurate and can be used for the determination clebopride tablets and its related substances.
-----参考文献：---------------------------------------------------------------------------------------
1Philip RR,Michael DJ.Determination of clebopride in plasma by capillary gas chromatography-negative-ion chemical ionization mass spectrometry.J Chromatogr B:Biomed Sci Appl,1988,432:153
2Robinson PR,Jones MD.Simultaneous determination of clebopride and a major metabolite N-desbenzylclebopride in plasma by capillary gas chromatography-negative-ion chemical ionization mass spectrometry. J Chromatogr:Biomed Appl,1991,564:147
3New Drug Official Standard in Drug Standard of China(国家药品标准新药转正标准)WS1-(X-110)-2003Z:114
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