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目的:建立离子对高效液相色谱法测定左卡尼汀注射液中杂质A的含量。方法:采用Zorbax SB-C18色谱柱(4.6 mm×250 mm,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-1氢氧化钠溶液调pH至3.0,加水至2000 mL),加庚烷磺酸钠1.1 g,振摇使溶解]-甲醇(95∶5),流速1.0 mL.min-1,检测波长为215 nm。结果:左卡尼汀杂质A与主药峰得到良好分离,分离度达到1.772,在1～100μg·mL-1的范围内,杂质A浓度与峰面积之间呈现良好线性关系,r2=0.9996(n=6),3批左卡尼汀注射液中杂质A的平均含量为0.0052%。结论:该方法简便、准确、专属,可用于该注射液的质量控制。
Objective: To establish an ion-pair high performance liquid chromatographic method for the determination of impurity A in levocarnitine injection. METHODS: Zorbax SB-C18 column (4.6 mm × 250 mm, 5 μm) was used. The mobile phase consisted of phosphate buffer (11.5 mL of phosphoric acid, 1800 mL of water and 1 mol·L -1 sodium hydroxide solution pH = 3.0, add water to 2000 mL), add heptane heptane sulfonate 1.1 g and shake to dissolve] -methanol (95: 5) at a flow rate of 1.0 mL · min-1 with a detection wavelength of 215 nm. Results: The impurity of levocarnitine was well separated from the main drug peak and the resolution was 1.772. The linear range of impurity concentration was in the range of 1 ~ 100μg · mL-1, r2 = 0.9996 ( n = 6). The average content of impurity A in three batches of levocarnitine injection was 0.0052%. Conclusion: The method is simple, accurate and specific and can be used for the quality control of the injection.