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目的:采用高效液相色谱法建立注射用甲硫氨酸维B1杂质的检查方法。方法:十八烷基硅烷键合硅胶色谱柱;流动相为0.05mol/L磷酸二氢钾溶液(含0.005mol/L庚烷磺酸钠,磷酸调节p H值至2.8)-甲醇(85:15);检测波长为201nm;流速为1.0ml/min。结果:本方法专属性试验、最小检测限试验、耐用性试验均符合方法学试验要求。结论:该测定方法操作简便、准确度高、可靠、操作性强,可作为注射用甲硫氨酸维B1的有关物质的测定,以控制其质量。
OBJECTIVE: To establish an HPLC method for the determination of methionine B1 in injection. METHODS: Octadecylsilane bonded silica gel column was used. The mobile phase consisted of 0.05 mol / L potassium dihydrogen phosphate solution (containing 0.005 mol / L sodium heptane sulfonate and pH adjusted to pH 2.8 by phosphoric acid) - methanol (85: 15); detection wavelength of 201nm; flow rate of 1.0ml / min. Results: The method specificity test, minimum detection limit test, durability test are in line with the methodological test requirements. Conclusion: The method is simple, accurate, reliable, and easy to operate. It can be used as the determination of related substances of methionine B1 for injection to control its quality.