HPLC法测定左旋卡尼汀氯化钠注射液含量及有关物质

HPLC measurement of levocarnitine content and related substances in levocarnitineand sodium chloride injection

目的建立左旋卡尼汀氯化钠注射液含量及有关物质的HPLC测定方法.方法采用Spherigel-C18柱(250 mm×4.6 mm,5 μm),以0.05 mol·L-1磷酸盐缓冲液(庚烷磺酸钠12 mg,pH2.4)-甲醇(9∶ 1)为流动相,检测波长225 nm.结果在选定色谱条件下,有关物质与主药完全分离,左旋卡尼汀在1～6 g·L-1范围内线性关系良好,平均回收率为99.91%.结论本法简便、准确,专属性好,可用于左旋卡尼汀氯化钠注射液含量及有关物质检测.

Aim To establish a method for measurement of levocarnitine content and related substances in levocarnitine and sodium chloride injection. Methods The chromatographic conditions adopted were ：Spherigel-C18 column （250 mm × 4.6 mm,5μm） , a mobile phase of O.05 tool · L^-1 phosphate buffer（ CH3 （ CH2 ） 5 SO3Na 12mg, pH2.4 ） -CH3 OH （ 9：1 ） , and a detection wavelength of 225 nm. Result The related substances can be completely seprarated from levocarnitine. For levocarnitine,a linear range of 1～6 g·L^-1, an average recovery of 99.91 % were obtained. Conclusion A simple, accurate and specific method is established for determination of levocarnitine in levocarnitine and sodium chloride injection and its related substances.