法测定左卡尼汀注射液的含量及有关物质

目的:建立简便快捷的左卡尼汀注射液含量及有关物质测定方法。方法:采用Alltech^® Brava Amino色谱柱(250 mm×4.6 mm,5 μm),柱温40 ℃,以0.01 mol·L^-1磷酸盐缓冲液-乙腈(25:75)为流动相,流速1.0 mL·min^-1,检测波长205 nm。结果:左卡尼汀与各有关物质及降解产物色谱峰分离度良好,各杂质峰互不干扰。左卡尼汀、杂质A、杂质B、杂质C、杂质D质量浓度分别在436.2~2 617、3.5~87.4、2.8~56、1.79~44.8、2.54~50.8 μg·mL^-1范围内线性关系良好,平均回收率(n=9)分别为100.0%、100.1%、101.6%、95.7%和102.5%,其定量限(S/N=10)分别为167.50、4.20、22.40、60.48和30.48 ng。结论:方法学验证结果表明,本法可用于左卡尼汀注射液的质量控制。

Objective: To establish an HPLC method for the determination of the content and related substances of levocarnitine injection.Methods: The Alltech^® Brava Amino column (250 mm×4.6 mm, 5 μm) was used with a mobile phase consisting of 0.01 mol·L^-1 potassium dihydrogen phosphate buffer solution and acetonitrile (25:75) at a flow rate of 1.0 mL·min^-1.The detection wavelength was 205 nm and the column temperature was 40 ℃.The injection volume was 10 μL.Results: The related substances and degraded products were completely separated from levocarnitine.And an excellent separation was achieved for the related substances.The calibration curves for levocarnitine, impurity A, impurity B, impurity C and impurity D revealed good linearities in the range of 436.2-2 617 μg·mL^-1, 3.5-87.4 μg·mL^-1, 2.8-56 μg·mL^-1, 1.79-44.8 μg·mL^-1, 2.54-50.8 μg·mL^-1, respectively.The average recoveries (n=9) of the above compounds were 100.0%, 100.1%, 101.6%, 95.7% and 102.5%, respectively.The limits of quantification (S/N=10) of these compounds were 167.50 ng, 4.20 ng, 22.40 ng, 60.48 ng and 30.48 ng respectively.Conclusion: The methodological validation results indicate that the established method can be applied to quality control of levocarnitine injection.

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