HPLC法测定注射用盐酸哌甲酯中的有关物质

发布时间：2018-08-11 16:00

【摘要】：目的:建立测定注射用盐酸哌甲酯中有关物质的方法。方法:采用高效液相色谱法。色谱柱为Waters symmetry C_(18),流动相为甲醇-0.01 mol/L磷酸二氢钾溶液(60∶40,V/V),流速为1.0 m L/min,检测波长为210 nm,柱温为35℃,进样量为10μL。结果:杂质A、杂质B检测质量浓度线性范围均为0.02~3.0μg/m L(r均为0.999 8);定量限分别为0.2、0.6 ng,检测限分别为0.06、0.2 ng;精密度、稳定性、重复性试验的RSD2.0%;加样回收率分别为98.2%~100.0%(RSD=0.56%,n=9)、98.0%~100.3%(RSD=0.70%,n=9)。结论:该方法操作简便、结果准确,适用于注射用盐酸哌甲酯中有关物质的测定。
[Abstract]:Objective: to establish a method for the determination of related substances in methylphenidate hydrochloride for injection. Methods: high performance liquid chromatography was used. The chromatographic column was Waters symmetry C18, the mobile phase was methanol-0.01 mol/L potassium dihydrogen phosphate solution (60: 40 V / V), the flow rate was 1.0 mL / min, the detection wavelength was 210nm, the column temperature was 35 鈩，

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