高效液相法测定甲硫氨酸维B1注射液的含量及其有关物质

目的建立了甲硫氨酸VitB1注射液的含量及其有关物质的HLPC测定方法，并进行了方法学研究。方法采用HLPC法，色谱柱为迪玛-C18色谱柱（4．6mm×250mm，5μm）；流动相为1mmol／L己烷基磺酸钠溶液（含0．2％三乙胺，用50％磷酸溶液调节pH值5．0）：甲醇（85：15）；流速为1．0ml／min；检测波长：228nm。结果甲硫氨酸及VitB1的主峰与杂质峰得到很好的分离，且重复性、精密度良好；甲硫氨酸浓度在201～1005μg／ml范围内、VitB1在20．2～101．0μg／ml范围内呈良好的线性，甲硫氨酸r=0．9967、VitB1r=0．9999；最低检测限4．04ng。结论本法能准确的测定甲硫氨酸维B1注射液的有关物质及其含量，且方法简便，结果准确。

Determination of methiouine and VitB1 in injection and its related substance by HPLC

Objective To establish an HPLC method for the determination of Methiouine and VitB1 in injection and its related substance. Methods Diamonsil-C18 column（4. 6 mm× 250 mm, 5 μm） was used as the stationary phase; 1 mmol/L sodium hexanyl sulfonate solution （contains 0. 2% Triethylamine, with 50% Phosphoric acid adjusted the solution pH 5.0） ：methanol（85 ： 15）as mobile phase with a flow rate of 1.0 ml/ min. The detect wavelength was 273 nm. Results （ Methiouine and VitB1 ） Main peak, foreign matter peak were separated,and repeated, precision were good; methiouine and VitaminB1 were good linear obtained within the range of 20.1-100. 5 μg·ml^-1,20. 2-101.0 μg/ml. Methiouine r =0. 996 7, VitaminB1 r =0. 999 9;the detection limits were 4.04 ng. Conclusion This method is simple and accurate which can be used to determination of Methiouine and VitaminB1 in injection and its related substance.