A method was established to determine the content of Levocarnitine injection by HPLC. The Zorbax SB-Clg column(4.6 mm x250 mm,5 jim) was used , phosphate buffer solution[ (11. S mL phosphoric acid was dissolved in 1 800 mL water,adjusted to pH 3.0 with 1 mol · L-1 sodium hydroxide solution, and bring up to full volume 2 000 mL with water) , 1. 1 g sodium heptanesulfonate was added and dissolved by shaking]; methanol (95:5) as mobile phase, at a flow rate of 1.0 mL · min"1, at detection wavelength 225 nm. As a result, the linearity of peak area was good when the injected quantity of Levocarnitine was in the range of 0.04 ~ 3.0 mg ? mL "' (r = 0. 999 9, n = 6). The recovery of the method was 99. 78% , the content of Levocarnitine injection was 98.46% ~ 100.9%. It can be concluded that the method is specific, accurate and convenient, and can be used for quality control of the Levocarnitine injection.%建立了高效液相色谱法测定左卡尼汀注射液含量.采用Zorbax SB-C1s色谱柱(4.6mm×250mm,5μm),流动相为磷酸盐缓冲液[(取磷酸11.5 mL,加水约1800 mL,用1 moL/L氢氧化钠溶液调节至pH3.0,加水至2 000 mL),加庚烷磺酸钠1.1g,振摇使溶解]一甲醇(95∶5),流速1.0mL·min-1,检测波长为225 nm.结果表明,在0.04 ～3.0 mg/mL的范围内,浓度与峰面积之间呈现良好线性关系,r2 =0.999 8(n=7),左卡尼汀注射液含量为标示量98.46％ ～ 100.9％,平均回收率为99.78％ (n =9).该法简便、准确、专属,可用于该注射液的质量控制.
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