文章摘要
李尚,徐佳雯,张斐.HPLC法同时测定琥珀酸曲格列汀中9个杂质的含量[J].药学与临床研究,2021,29(2):12~16
HPLC法同时测定琥珀酸曲格列汀中9个杂质的含量
Simultaneous Determination of Nine Impurities in Tragaliptin Succinate by HPLC
投稿时间:2020-06-29  修订日期:2021-04-13
DOI:
中文关键词: 琥珀酸曲格列汀  高效液相色谱  校正因子  有关物质
英文关键词: Tragaliptin succinate  HPLC  Correction factor  Related substances
基金项目:
作者单位E-mail
李尚 徐州医科大学 1223903571@qq.com 
徐佳雯 徐州医科大学  
张斐 江苏福锌雨医药科技有限公司 zhangfeily@126.com 
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中文摘要:
      目的:建立高效液相色谱法同时测定琥珀酸曲格列汀中9个杂质的含量。方法:采用Welch Utimate AQ C18(4.6 mm × 250 mm,5 μm)色谱柱,以0.1%磷酸溶液-乙腈为流动相,梯度洗脱,流速1.0 mL·min-1,柱温35 ℃,检测波长230 nm。结果:该药与已知杂质Ⅰ~Ⅸ色谱峰之间的分离度良好;该药和已知杂质Ⅰ~Ⅸ分别在各自的线性范围内线性关系均良好(r2≥0.9999),杂质Ⅰ~Ⅸ的校正因子分别为1.3、0.9、0.5、1.2、1.2、1.0、2.1、2.3、1.0,且该药和已知杂质Ⅰ~Ⅸ的平均回收率均在99.0%~101.0%。结论:该方法专属性强,重复性好,可用于测定该药中的有关物质。
英文摘要:
      Objective: To establish an HPLC method for simultaneous determination of 9 impurities in tragaliptin succinate. Methods: The analysis was performed by HPLC with a Welch Utimate AQ C18 column (4.6 mm × 250 mm, 5 μm), the mobile phase was an acetonitrile-0.1% phosphoric acid aqueous solution gradiently eluted at 1.0 mL·min-1, the column temperature was 35 ℃ and the detection wavelength was 230 nm. Results: The resolutions between the peaks of tragaliptin succinate and nine known impuritiesⅠ-Ⅸ were good. Tragaliptin succinate and the known impurities Ⅰ-Ⅸ had good linear relationships in their respective linear ranges (r2≥0.999) with average recoveries at 99.0%-101.0%, the correction factors for the impurities Ⅰ-Ⅸ were 1.3, 0.9, 0.5, 1.2, 1.2, 1.0, 2.1, 2.3 and 1.0. Conclusion: This method is specific and accurate, and can be used to detect related substances in tragaliptin succinate.
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