【摘要】 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。更多还原

【Abstract】 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.更多还原