高效液相色谱法测定注射用甲硫氨酸维B_1中维生素B_1含量

Determination of Vitamin B_1 in Methionine and Vitamin B_1 for Injection by HPLC

目的探讨用高效液相色谱(HPLC)法测定注射用甲硫氨酸维B1的维生素B1含量。方法采用C18色谱柱(150mm×4.6mm,5μm),以混合溶液(取庚烷磺酸钠12g,加少量水溶解,再加三乙胺12mL,加水稀释至1000mL,用磷酸调pH值至3.2即可)-甲醇(80∶20)为流动相,检测波长为246nm。结果维生素B1质量浓度在4～32μg/mL范围内与峰面积线性关系良好,r=0.9993,平均回收率为100.3%,RSD为0.54。结论HPLC法精密可靠,可作为注射用甲硫氨酸维B1的质量控制方法。

Objective To estalish a method for the determination of vitamin B1 in methionine and vitamin B1 for injection by HPLC. Methods HPLC conditions were CIS column（150 mm×4. 6 mm, 5μm）, mixtures（extracted sodium heptanesulfonate 12 g, solved with a small amount of water, then added triethylamine 12 mL, diluted to 1 000 mL water, pH was adjusted to 3.2 with phosphoric acid）-methanol（80：20）as the mobile phase and 246 nm as the detective wave length. Results The linear range of vitamin B1 was 4- 32 g/mL, r=0. 999 3. The average recovery rate was 100. 3%, RSD was 0. 54. Conclusion This method is precise and credible. It can be applied to the quality control of methionine and vitamin B1 for injection.