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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 a method for determining the content of methionine VitB1 injection and its related substances by using HLPC method. Methods The HLPC method was used. The mobile phase consisted of Dima-C18 column (4.6 mm × 250 mm, 5 μm). The mobile phase consisted of 1 mmol / L sodium hexanesulfonate solution containing 0.2% triethylamine and adjusted with 50% phosphoric acid pH 5.0): methanol (85:15); flow rate 1.0 ml / min; detection wavelength: 228 nm. Results The main peaks and impurity peaks of methionine and VitB1 were well separated with good reproducibility and precision. The methionine concentration was in the range of 201-1005μg / ml and that of VitB1 was in the range of 20.2-101.0μg / ml Showed good linearity, methionine r = 0.9967, VitB1r = 0.9999; the minimum detection limit was 4.04ng. Conclusion This method can accurately determine the relevant substances and their contents of methionine and vitamin B1 injection, and the method is simple and accurate.