| 耿庆光,王 发.加校正因子的主成分自身对照法测定奥硝唑片和胶囊中有关物质含量[J].安徽医药,2015,19(11):2081-2082. |
| 加校正因子的主成分自身对照法测定奥硝唑片和胶囊中有关物质含量 |
| HPLC method with correction factor for the determination of relatedsubstances in ornidazole tablets and capsules |
| 投稿时间：2015-04-06 |
| DOI： |
| 中文关键词: 奥硝唑 校正因子 自身对照 有关物质 杂质Ⅰ |
| 英文关键词: ornidazole correction factor self contrast related substance impurity I |
| 基金项目: |
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| 中文摘要: |
| 目的 建立加校正因子的主成分自身对照法测定奥硝唑片和胶囊中有关物质含量的方法。方法 Agilent C18色谱柱(250 mm×4.6 mm,5 μm),流动相:甲醇—水(20 ∶80),流速:1.0 mL·min-1,柱温:35℃,检测波长:318 nm。分别测定奥硝唑和杂质Ⅰ(2-甲基-5-硝基咪唑)的线性方程,以斜率计算杂质Ⅰ相对于奥硝唑的校正因子,用相对保留时间确定其位置,其他有关物质的含量采用自身对照法计算。结果 杂质Ⅰ的相对保留时间为0.23,校正因子为0.80。结论 该法简单、准确, 更适用于奥硝唑片和胶囊中有关物质的控制。 |
| 英文摘要: |
| Objective To determine the content of related substances in ornidazole tablets and capsules by using self contrast and correction factor method.Methods The Agilent C18 (250mm×4.6mm,5μm)column was used.The mobile phase was methanol-water(20∶80)with a flow rate of 1.0 mL.min-1.The temperature of column was set at 35℃ and the detection wavelength was at 318 nm .The slope of linear equation was used to determine the correction factor between Impurity Iand ornidazole.The relative retention time was used to determine the position of Impurity I.Results The relative retention time between Impurity Iand ornidazole was 0.23,the correction factor of Impurity Ibeing 0.80.Conclusion The method was simple and accurate,which is proposed for analyzing the related substances in ornidazole tablets and capsules. |
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