| 摘要: |
| 目的 建立高效液相色谱法测定硫酸氢氯吡格雷片中氯吡格雷及有关物质含量的测定方法，并比较3个厂家生产的氯吡格雷片的有效成分和杂质含量的差异。方法 色谱条件为：ULTRON ES-OVM手性色谱柱（5μm，4 .6mm×150 mm），乙腈-0.01M磷酸二氢钾溶液（20:80）为流动相，流速为1 ml/min，柱温17℃，检测波长220 nm。 结果 硫酸氢氯吡格雷及有关物质分别在在50mg/L~117mg/L和1.52mg/L~30.4mg/L范围内线性关系良好（相关系数r均为0.9998），精密度良好，平均回收率分别为100.2%和99.7%，供试品溶液室温放置12小时稳定；三个厂家生产的硫酸氢氯吡格雷片含量及有关物质均符合药典要求。结论 本方法准确度好，专属性强，可用于硫酸氢氯吡格雷及其有关物质的含量测定。 |
| 关键词: 高效液相色谱法 硫酸氢氯吡格雷 有关物质 不同厂家 含量测定 |
| DOI：10.3724/SP.J.1008.2014.00924 |
| 投稿时间：2014-03-20修订日期：2014-05-26 |
| 基金项目:] 1.国家自然科学(NO.81272819);国家自然科学基金;国家自然科学基金青年科学基金项目 |
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| Determination of different manufacturers of Clopidogrel Hydrogen Sulfate and Its related Substances by HPLC |
| Tai ZongGuang,Zhu QuanGang,Zhang Wei,Wang Xiaoyu,Dai ZiYuan,Zhang Lijuan,Gao Shen |
| (Department of Pharmaceutics,Changhai Hospital,Second Military Medical University) |
| Abstract: |
| Objective A HPLC method for quantitative determination of clopidogrel hydrogen sulfate and its related substances was established .We also compared the content of effective components and impurity of clopidogrel tablets from three manufactures. Method an UL-TRON ES-OVM column (5μ m, 4.6mm × 150 mm) was used, The mobile phase consisted of a mixture of acetonitrile and 0.01M potassium dihydrogen phosphate solution (20:80). The flow-rate was 1ml/min, the column temperature 17℃, the UV detection was performed at 220 nm. Result Clopidogrel Hydrogen Sulfate and its related substances in 50 mg/L~117 mg/L and 1.52mg/L~30.04 mg/L were respectively in good linear relationship (correlation coefficient r = 0.9998). Conclusion The method is accurate and has good specificity. It can be used for the determination of Clopidogrel Hydrogen Sulfate and its related substances. |
| Key words: High performance liquid chromatography Clopidogrel Hydrogen Sulfate Related substances Determination of content |
