【摘要】：目的:建立測定注射用鹽酸哌甲酯中有關物質(zhì)的方法。方法:采用高效液相色譜法。色譜柱為Waters symmetry C_(18),流動相為甲醇-0.01 mol/L磷酸二氫鉀溶液(60∶40,V/V),流速為1.0 m L/min,檢測波長為210 nm,柱溫為35℃,進樣量為10μL。結(jié)果:雜質(zhì)A、雜質(zhì)B檢測質(zhì)量濃度線性范圍均為0.02~3.0μg/m L(r均為0.999 8);定量限分別為0.2、0.6 ng,檢測限分別為0.06、0.2 ng;精密度、穩(wěn)定性、重復性試驗的RSD2.0%;加樣回收率分別為98.2%~100.0%(RSD=0.56%,n=9)、98.0%~100.3%(RSD=0.70%,n=9)。結(jié)論:該方法操作簡便、結(jié)果準確,適用于注射用鹽酸哌甲酯中有關物質(zhì)的測定。
[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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