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目的:对合成的唑来膦酸中有关物质1H-咪唑-1-醋酸进行检查研究,确定有关物质检查方法。方法:参照中国药典,对流动相进行筛选;确定吸收波长;研究HPLC法的专属性;探索有关物质的计算方法。结果:以甲酸溶液(0.8mL→1000mL)为流动相(用2mol.L-1氢氧化钠溶液调节pH值3.7±0.2);检测波长为210nm;采用HPLC法分离测定1H-咪唑-1-醋酸含量。结论:该方法可有效分离唑来膦酸与1H-咪唑-1-醋酸,能有效测定唑来膦酸中有关物质1H-咪唑-1-醋酸的含量。
OBJECTIVE: To investigate the related substances 1H-imidazole-1-acetic acid in the synthesized zoledronic acid, and to determine the related substances inspection methods. Methods: With reference to Chinese Pharmacopoeia, the mobile phase was screened; the absorption wavelength was determined; the specificity of HPLC method was explored; and the calculation method of related substances was explored. Results: Formic acid solution (0.8mL → 1000mL) was used as the mobile phase (pH was adjusted to 3.7 ± 0.2 with 2mol.L-1 sodium hydroxide solution). The detection wavelength was 210nm. 1H- content. Conclusion: This method can effectively separate zoledronic acid and 1H-imidazole-1-acetic acid, which can effectively determine the content of 1H-imidazole-1-acetic acid in zoledronic acid.