中国药典与美国药典中盐酸克林霉素有关物质及含量测定方法的比较

Comparison between methods of determination of clindamycin hydrochloride and related substances control in USP and ChP

目的 比较并讨论美国药典 (USP)和中国药典 (ChP)中盐酸克林霉素有关物质及含量测定方法。方法 HPLC ,色谱柱 :AgilentAnalyticalExtend C18(4.6mm× 2 5 0mm ,5 μ)。USP中流动相为磷酸盐缓冲液 (pH7.5 ) 乙腈 (5 5∶4 5 ) ,检测波长2 10nm ;ChP中流动相为磷酸盐缓冲液 (pH3.0 ) 甲醇 (2 10∶30 0 ) ,检测波长 2 14nm .结果 美国药典方法对三个杂质进行了定性 ,对杂质限度要求严格 ,峰形柱效较理想。中国药典方法对系统要求较低 ,适用性试验较易通过。通过调整中国药典方法流动相组成及样品浓度 ,发现有杂质未被分离。结论 中国药典方法易于普及 ,而美国药典方法分离效果好 。

OBJECTIVE Different HPLC methods of determination of clindamycin hydrochloride and related substances control in USP and ChP were compared and discussed. METHOD The HPLC method was used in which an Agilent Analytical Extend C18(4.6mm×250mm, 5μ) column , phosphate buffer (pH7.5) acetonitrile (55∶45) as mobile phase with detection at 210nm in USP , phosphate buffer(pH3.0) methanol(210∶300) as mobile phase and 214nm as detection wavelength in ChP. RESULTS Three related substances were identified and relatively optimal resolutions , theoretical plates and symmetries were attained by applying the method in USP with demanding chromatographic system. It was noticed that there were impurities unseparated by adjusting concentration of samples and mobile phase in ChP.CONCLUSION The method in ChP can be easily promoted in China whereas that in USP is more sensitive and accurate.