气相色谱法测定盐酸艾司洛尔注射液中的甲醇含量

摘要

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 28.16μg~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 8.112ng~243.36ng(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.%目的：建立气相色谱法测定盐酸艾司洛尔注射液中的甲醇含量。方法：色谱柱：HP-INNOWaX：30m×0.25μm×250μm；载气：氮气；检测器：FID火焰检测器；进样口温度250℃；检测器温度250℃。结果：甲醇在5.02～100.51μg/mL范围内有良好的线性关系，r=0.9998；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；平均回收率为99.94%（n=6），RSD%=0.31%。结论：本法简单、准确、重复性好，区分力强，可作为盐酸艾司洛尔注射液中甲醇的质控方法。