HPLC法测定左卡尼汀注射液中的含量及有关物质A

摘要

目的：建立HPLC法测定左卡尼汀注射液中的含量及有关物质A。方法：色谱柱：硅胶为填充剂（250mm×4.6mm，5um）；乙腈∶磷酸盐缓冲液（0.05mol/L磷酸氢二钠，用稀磷酸调pH值为5.50）=60∶40为流动相；检测波长为205nm；流速为1.0ml/min。结果：左卡尼汀在28.16～52.30μg范围内呈良好的线性关系，r=0.9999；平均回收率（n=6）为99.70%，RSD=0.51%；有关物质A在8.11～243.36ng范围内呈良好的线性关系，r=1.0000；平均回收率（n=6）为100.07%，RSD=0.36%。结论：本法简单、准确、重复性好、区分力强，可作为左卡尼汀注射液的质控方法。%Objective To establish a HPLC method for determination of the content and related compound A in Levocarnitine injection. Methods A column of silicagel column was adopted;and the mobile phase was the mixture of acetonitrile-phosphate buffer(0.05mol/Lsodium hydrogen phosphate,with phosphoric acid to adjust pH 5.5)=60∶40;The detection wavelength was set at 205nm;the flow rate was 1.0ml/min.Results Levocarnitine showed a good linear relationship in the range of 28.16~52.30μg (r=0.9999);The average recovery (n=6)was 99.70%(RSD=0.51%);The related compound A of Levocarnitine showed a good linear relationship in the range of 8.112~243.36 ng (r=1.0000);The average recovery (n=6) was 100.07%(RSD=0.36%). Conclusion The method is simple,accurate and reproducible,which can be uses for the quality control of Levocarnitine injection.