HPLC法测定盐酸氯哌丁原料药的有关物质

目的:建立以高效液相色谱法测定盐酸氯哌丁原料药中有关物质的方法。方法:色谱柱为Agilent C18,流动相为0.02mol.L-1磷酸二氢钾溶液-甲醇(30:70,三乙胺1.0mL,用磷酸调pH至3.5),检测波长为225nm,流速为1.0mL.min-1,柱温为室温,进样量为20μL。结果:有关物质与主药达到有效分离,杂质峰面积之和约相当于自身对照溶液主成分峰面积的0.13%～0.26%。结论:本方法操作简便、结果准确、专属性强,可用于该原料药中有关物质的检测。

Determination of Related Substance in Cloperastine Hydrochloride by HPLC

OBJECTIVE:To determine the related substance in cloperastine hydrochloride by HPLC.METHODS:The analysis was conducted on Agilent C18 column with the mobile phase consisted of 0.02 mol·L-1 KH2PO4-methanol(30∶70,triethlaminel 1.0 mL,adjusted to pH=3.5 with phosphoric acid) at a flow rate of 1.0 mL·min-1.The detection wavelength was 225 nm;the column temperature was set at room temperature,and the injection volume was 20 μL.RESULTS:Effective segregation was achieved for the related substance from the chief chromatographic peak.The total peak area of the related substance in the sample was 0.13%～0.26% that of the main constituent of its reference substance(own control solution).CONCLUSION:The method is simple,accurate and specific,and applicable for the quality control of the related substance in cloperastine hydrochloride.