| 李群鑫,郑淑凤.HPLC法测定琥珀酸美托洛尔的含量及有关物质[J].中国药事,2017,(6):632-636 |
| HPLC法测定琥珀酸美托洛尔的含量及有关物质 |
| Determination of the Content and Related Substances of Metoprolol Succinate Using HPLC Method |
| 投稿时间：2017-01-09 |
| DOI：10.16153/j.1002-7777.2017.06.010 |
| 中文关键词: 琥珀酸美托洛尔 含量测定 有关物质 高效液相色谱法 |
| 英文关键词: Metoprolol Succinate determination of content related substances HPLC |
| 基金项目: |
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| 中文摘要: |
| 目的：建立高效液相色谱法测定琥珀酸美托洛尔的含量及有关物质。方法：色谱柱为C84.6 mm，5μm），以乙腈-十二烷基硫酸钠溶液（40︰60）为流动相，流速1.0 mg·mL-1，柱温30℃，检测波长223 nm。结果：琥珀酸美托洛尔与各主要杂质峰分离度符合规定，琥珀酸美托洛尔浓度在0.01641~0.1641 mg·mL-1范围内呈良好的线性关系（r=1.0000），回收率为100.4%，（RSD为0.9%，n=9）；供试品溶液在24 h内稳定。结论：本方法简便、准确、专属性强，可用于琥珀酸美托洛尔的含量测定和有关物质检查。 |
| 英文摘要: |
| Objective: To establish HPLC method to determine the content and related substances of Metoprolol Succinate. Methods: C8 column (150 mm × 4.6 mm, 5μm) was used with acetonitrile-sodium dodecyl sulfate solution (40:60) as the mobile phase at the flow rate of 1.0 mg·m-1. The column temperature was kept at 30℃ and the detection wavelength was 223 nm. Results: The degree of separation of Metoprolol Succinate and major impurity peaks met the requirements. The method had good liner relationship within the range of 0.01641-0.1641 mg·mL-1 (r=1.0000). The average recovery was 100.4% (RSD=0.9%, n=9). The solution was stable for 24 h. Conclusion: The method is simple, accurate, specifc and suitable for the determination of content and related substances of Metoprolol Succinate. |
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