甲硝唑片制剂有关物质测定

Determination of Related Substances in Metronidazole Tablets

摘要: 目的：采用高效液相色谱法测定甲硝唑片制剂中的有关物质并进行杂质谱研究。方法：以Welch Ultimate® XB-C18 (4.6 mm × 250 mm, 5 μm)色谱柱为分析柱；结果：甲硝唑与有关物质具有良好的分离度，分离度均大于2，并对3批自制甲硝唑片有关物质进行考察，与原研市售品相当，均满足质量控制标准。结论：本方法简便、快速、灵敏、准确，可作为甲硝唑片有关物质的检测方法，同时杂质谱研究有助于保证甲硝唑片质量标准性。

Abstract: Objective: To determine the related substances in metronidazole tablets preparation by high per-formance liquid chromatography and to study the impurity profile. Method: Welch Ultimate® XB-C18 (4.6 mm × 250 mm, 5 μm) chromatographic column was used as the analytical column; the results showed that metronidazole and related substances had a good resolution, and the resolution was greater than 2. The related substances of azole tablets were investigated, and they were equivalent to the original commercial products, and all met the quality control standards. Conclusion: This method is simple, rapid, sensitive and accurate. It can be used as a detection method for related substances in metronidazole tablets. At the same time, the study of impurity profile can help ensure the quality standard of metronidazole tablets.