高效液相法测定甲硫氨酸维B_1注射液的含量及其有关物质

Determination of methiouine and VitB_1 in injection and its related substance by HPLC

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。

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.