摘要
运用二极管阵列检测器结合峰纯度分析建立利培酮有关物质HPLC的测定方法。采用C18色谱柱(Kromasil,C18,5μm,4.6×200mm),以1.0%三乙胺缓冲溶液(以磷酸调节pH值至3.0)∶乙腈(70∶30)为流动相,流速为0.8mL/min,柱温为30℃,检测波长为260nm。利培酮与有关物质分离良好,原料1、中间体1、中间体2以及利培酮检出限分别为0.4、4、0.4、0.6ng。二极管阵列检测器结合峰纯度分析可用于HPLC测定利培酮有关物质时色谱条件的选择和评价,本方法简单、快速、专属性好、灵敏度高。
A new HPLC method to determine related substances in risperidone by DAD and peak purity analysis was established,using C18 column(Kromasil,C18,5μm,4.6×200mm),acetonitrile-1% triethylamine buffer(30:70)(adjust pH to 3.0 by phosphoric acid)as mobile phase.The flow rate is 0.8mL/min;the column oven temperature is 30℃;the detection wavelength is 260nm.Risperidone and related substances are well separated; the LOD of raw material 1,intermediate 1,and intermediate 2 were 0.4,4,0.4,and 0.6ng.DAD and peak purity analysis is useful for evaluation of determination of related substances in risperidone by HPLC; the method is simple,fast,specific and sensitive.
出处
《光谱实验室》
CAS
CSCD
北大核心
2010年第4期1473-1476,共4页
Chinese Journal of Spectroscopy Laboratory