【摘要】 目的:用HPLC法同时测定复方甲硫氨酸维B1注射液中甲硫氨酸和维生素B1的含量,为复方甲硫氨酸维B1注射液的含量测定提供检测方法,制定质控标准。方法:用十八烷基键合硅胶为填充剂;0.005mol.L-1庚烷磺酸钠溶液(pH=3.0)与乙腈为流动相,梯度洗脱;检测波长为210nm;柱温30℃;流速约为1.0mL.min-1。结果:甲硫氨酸与维生素B1分别能与相邻杂质峰较好分离,甲硫氨酸的浓度在0.10~2.10mg.mL-1范围内线性相关性良好,维生素B1的浓度在0.011~0.21mg.mL-1范围内线性相关性良好。结论:该法简便、准确、专属性好,可以用于甲硫氨酸维B1注射液的含量测定。更多还原

【Abstract】 Objective: To establish the HPLC method for the determination of methionine and vitamin B1 in metnionine-vitamin B1 injection. Methods: The HPLC system consisted of a C18 chromatographic column and a mixture of acetonitrile and 0.005 mol·L-1 heptane sulfonic acid sodium solution(pH=3.0) as a mobile phase used for gradient elution.The flow rate was 1.0 mL·min-1 with a detection wavelength at 210 nm and column temperature 30 ℃.Results: Methionine and vitamin B1 could be completely separated from other impurities.The linear range of methionine was 0.10～2.10 mg·mL-1 and vitamin B1 was 0.011～0.21 mg·mL-1 respectively.Conclusion: The method was simple,accurate,suitable for the determination of methionine and vitamin B1 in methionine and vitamin B1 injection.更多还原