| 郑家晴,郭丽娟,周翠松.HPLC法测定替格瑞洛片中的有关物质[J].中国药品标准,2016,17(3):198-203 |
| HPLC法测定替格瑞洛片中的有关物质 |
| HPLC Method for the Determination of Related Substances in Ticagrelor Tablets |
| 投稿时间：2016-03-11 修订日期：2016-05-02 |
| DOI： |
| 中文关键词: 替格瑞洛片 高效液相色谱法 有关物质 |
| 英文关键词: Ticagrelor Tablets HPLC related substances |
| 基金项目: |
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| 中文摘要: |
| 目的：建立HPLC法测定替格瑞洛片中的有关物质的方法。方法：采用Agilent Zorbax SB-C18色谱柱 (4.6 mm × 150 mm, 1.8 μm)；以磷酸盐缓冲液-乙腈为流动相，梯度洗脱；流量1.0 mL? min -1；柱温55 ℃；检测波长242 nm。结果：在该色谱条件下，替格瑞洛与各杂质峰分离度良好。结论：建立的方法灵敏度高，专属性强，可用于替格瑞洛片生产中有关物质的检测。 |
| 英文摘要: |
| Objective：To develop an HPLC method for the determination of related substances in Ticagrelor Tablets. Method：The assay was performed on an Agilent Zorbax SB-C18 column (4.6 mm × 150 mm, 1.8 μm) with phosphate buffer solution - acetonitrile as mobile phase , gradient elution at a flow rate of 1.0 mL? min -1；The column temperature was 55 ℃ and detection wavelength was 242 nm. Results：Ticagrelor and impurity peaks could be well separated under the HPLC conditions. Conclusion：The method is sensitive and specific, which could be used to detect the related substances in Ticagrelor Tablets. |
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