文章摘要
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:
作者单位
李群鑫 厦门市食品药品质量检验研究院, 厦门 361012 
郑淑凤 厦门市食品药品质量检验研究院, 厦门 361012 
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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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