HPLC法测定注射用左卡尼汀的含量

Determination of the Content of Levocarnitine for Injection by HPLC

目的:建立HPLC法测定注射用左卡尼汀的含量。方法:色谱柱为C18柱(150mm×4.6mm,5μm),流动相为磷酸盐缓冲液(取磷酸11.5ml,加1mol/L氢氧化钠溶液100ml,加水稀释至2000ml,用饱和氢氧化钠溶液调节pH值至2.4)-甲醇-庚烷磺酸钠(980ml:20ml:0.555g),检测波长为225nm,流速为1.0ml/min,理论板数应不低于1200。结果:左卡尼汀在0.28mg/ml～2.26mg/ml浓度范围内与峰面积呈良好的线性关系(r=0.9999);平均回收率为99.9%。RSD为0.92%。结论:此方法快捷、准确,可作为注射用左卡尼汀质量控制的方法。

Objective：To establish a HPLC method for determination of Levocarnitine for Injection.Methods：The analytical column was C18 column（150mm × 4.6mm,5μm）;mobile phase：consisted of phosphate buffer solution（Taking phosphate 11.5ml,plus 1mol / L sodium hydroxide solution 100ml,diluted with water to 2000ml,with saturated sodium hydroxide solution to adjust pH value of 2.4）-Methanol-n-heptane sulfonate（980 ml：20 ml：0.555g）.The detection wavelength was 225nm,The flow rate was 1.0ml/min.Number of theoretical plates should not be less than 1200.Results：0.28mg/ml ~ 2.26mg/ml Levocarnitine in the concentration range of a good linear relationship with the peak area（r=0.9999）.The average recovery was 99.8%.RSD was 0.92%.Conclusion：：This method is fast,accurate and can be used as quality control of Levocarnitine for Injection method.