| 梯度洗脱HPLC法测定盐酸克林霉素棕榈酸酯及制剂的有关物质 |
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| 引用本文： | 王建,王红波,孟磊,洪利娅.梯度洗脱HPLC法测定盐酸克林霉素棕榈酸酯及制剂的有关物质[J].药物分析杂志,2012(2):314-317. |
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| 作者姓名： | 王建 王红波 孟磊 洪利娅 |
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| 作者单位： | 浙江省食品药品检验所;浙江工业大学;蚌埠医学院 |
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| 基金项目： | 国家药典委员会国家药品标准提高研究项目,编号国药典综发[2010]35号 |
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| 摘 要： | 目的:建立梯度洗脱HPLC法测定盐酸克林霉素棕榈酸酯原料药、分散片、颗粒及干混悬剂的有关物质。方法:采用Agilent ZORBAX XDB-C8(4.6 mm×150 mm,5μm)柱,流动相A为5 mmol·L-1醋酸铵溶液-乙腈(50∶50),流动相B为乙腈,流速为1.0 mL·min-1,线性梯度洗脱,检测波长为230 nm。结果:盐酸克林霉素棕榈酸酯与10种中间体、副产物完全分离。重复性RSD为2.9%,检测限为10μg·mL-1。结论:方法简便、灵敏、重复性好,可用于本品的质量控制。
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| 关 键 词： | 盐酸克林霉素棕榈酸酯 杂质 中间体 副产物 高效液相色谱法 |
Isocratic HPLC determination of related substances of clindamycin palmitate hydrochloride and its drug products |
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| WANG Jian,WANG Hong-bo,MONG Lei,HONG Li-ya.Isocratic HPLC determination of related substances of clindamycin palmitate hydrochloride and its drug products[J].Chinese Journal of Pharmaceutical Analysis,2012(2):314-317. |
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| Authors: | WANG Jian WANG Hong-bo MONG Lei HONG Li-ya |
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| Institution: | 1 (1.Zhejiang Institute for Drug Control,Hangzhou 310004,China; 2.Zhejiang University of Technology,Hangzhou 310004,China;3.Bengbu Medical College,Bengbu 233000,China) |
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| Abstract: | Objective:To develop isocratic HPLC method for the determination of related substances of clindamycin palmitate hydrochloride drug substance,dispersible tablets,granules and for suspension.Methods:The column was Agilent ZORBAX XDB-C8(4.6 mm×150 mm,5 μm.The mobile phase consisted of 5 mmol·L-1ammonium acetate solution-acetonitrile(50∶ 50)(A) and acetonitrile(B) with gradient program.The flow rate was 1.0 mL·min-1,and the detection wavelength was 230 nm.Results:Good separation of clindamycin palmitate and ten intermediates could be achieved.The RSD of precision was 2.9%.The detection limit was 10 g·mL-1.Conclusion:The method is simple,sensitive and reproducible,and can be used for quality control of clindamycin palmitate hydrochloride. |
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| Keywords: | clindamycin palmitate hydrochloride impurities intermediate by-product HPLC |
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