A method for determining the content and impurities of levocarnitine injection and its application
A technology for injection and impurities, which is applied in the determination of levocarnitine injection content and impurities by hydrophilic interaction chromatography, and in the field of determination of levocarnitine injection content and impurities, which can solve the requirements of low separation limit, column loss, theoretical Reduce the number of plates and other problems, to overcome the effect that is not easy to obtain
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[0033] The following examples help to further understand the present invention, but the present invention is not limited to these contents.
[0034] A method for determining the content and impurities of levocarnitine injection by hydrophilic interaction chromatography.
[0035] 1 material preparation
[0036] Shimadzu LC-20A high performance liquid chromatography system (including LC-20AT pump; DGU-20A degasser; SIL-20A autosampler; CTO-10ASvp column thermostat; SPD-20A UV detector; Lab solution chromatography Workstation); WatersXBridge Amide chromatographic column (4.6mm × 250mm, 3.5μm); 1 / 10,000 electronic balance (AR1140, OhausCorp.Brook, NJ, USA); 1 / 100,000 electronic balance (MS105Du type, METTLER TOLEDO); Electronic pH meter (pHMeter PHS-3C, Shanghai Jingke Industrial Co., Ltd.); ultrasonic cleaner (SK250HP, Wuxi Jianyi Experimental Equipment Co., Ltd.).
[0037] The reference substance of levocarnitine was provided by China National Institutes for Food and Drug Cont...
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