国产注射用阿莫西林钠中主要杂质分析

目的: 对国产注射用阿莫西林钠中的主要杂质进行分析。 方法: 采用高效液相色谱法,以Waters Nova-pak C₁₈ (250 mm×4.6 mm,5 μm)为色谱柱,检测波长为254 nm,梯度洗脱检查105批样品的有关物质。 结果: 在国产注射用阿莫西林钠中共检出19个杂质,其中主要杂质为阿莫西林青霉氧酸、二酮哌嗪阿莫西林、阿莫西林二聚体和阿莫西林三聚体,单个杂质含量均小于3%,总杂质含量均小于6%。 结论: 本研究结果对进一步指导该品种生产有重大意义。

Objective: To analyze the main impurities of amoxicillin sodium for injection made in China. Methods: The related substances of amoxicillin sodium for injection were determined by high performance liquid chromatography with gradient elution.Waters Nova-pak C₁₈ column (250 mm×4.6 mm,5 μm) was used,and the detecting wavelength was set at 254 nm. Results: 19 impurities were observed in most of the 105 batches of amoxicillin sodium for injection.The major impurities were penicilloic acids of amoxicillin sodium salt,amoxicillin diketopiperazines,amoxicillin dimer and amoxicillin trimer.The contents of single impurity were all less than 3% and the total contents of impurities were all less than 6%. Conclusion: The result had a great significance in optimizing the production process.