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
Isocratic HPLC determination of related substances of clindamycin palmitate hydrochloride and its drug products
分类号：
出版年·卷·期（页码）：2012,32 (2):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----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,5 μm)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10 μg·mL-1。 结论: 方法简便、灵敏、重复性好,可用于本品的质量控制。
-----英文摘要：---------------------------------------------------------------------------------------
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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