HPLC法测定左卡尼汀注射液含量及有关物质

HPLC determination of levocarnitine injection and its related substances

目的建立测定左卡尼汀注射液含量及有关物质的方法。方法采用高效液相色谱法,色谱柱：MC-Pack NH2色谱柱（4.6 mm×150 mm,5μm）;流动相：0.05 mol·L^-1磷酸盐缓冲液-乙腈（体积比35∶65）,磷酸调节pH至4.3;检测波长：205 nm;流速：1 mL·min^-1;柱温：30℃。结果左卡尼汀在1.048.30 mg·mL^-1质量浓度范围内与峰面积呈良好的线性关系,r=0.999 9;高、中、低3种浓度的平均回收率为100.7%,RSD为1.4%。左卡尼汀的检测限为3 ng,有关物质（E）-4-（三甲基氨基）-2-丁烯酯或（Z）-4-（三甲基氨基）-2-丁烯酯的检测限为0.02 ng。结论该法简便、准确、灵敏度高,重现性好,适用于左卡尼汀注射液的质量控制。

Objective To establish a HPLC method for the determination of levocarnitine Injection and its related substances.Method The HPLC was carried out on a YMC-Pack NH2（150 mm×4.6 mm,5μm） column with a flow rate of 1.0 mL·min-1 at column temperature 30 ℃,of which the mobile phase was consisted of 0.05 mol·L-1 solution of phosphate buffer and acetonitrile（35∶65,pH4.3） and the detected UV wavelength was 205 nm.Results The calibration curve was linear（r=0.999 9） in the range of 1.048.30 mg·mL-1 for levocarnitine,and the average recovery was 100.7%,with RSD 1.4%.The limit of detection was 3 ng for levocarnitine and 0.02 ng for its impurity A.Conclusion It is an accurate,simple,rapid,qualitative method with good reproducibility for the determination of levocarnitine and its related substances.