高效液相色谱法检查单硝酸异山梨酯缓释片中的有关物质  

Determine the Related Substances of Isosorbide Mononitrate Sustained Release Tablet by HPLC

作　　者：高永宝 康雨佳 刘畅[2] 陈烨[2] GAO Yong-bao KANG Yu-jia LIU Chang CHEN Ye(Certification Center for Drugs ,Liaoning ,Shenyang 110007, China Department of Pharmacy of Liaoning University,New Drug R ＆ D Key Laboratory of Liaoning Province, Shenyang 110036, China)

机构地区：[1]辽宁省药品认证中心,辽宁沈阳110007 [2]辽宁大学药学院辽宁省新药研发重点实验室,辽宁沈阳110036

出　　处：《辽宁大学学报（自然科学版）》2017年第3期251-256,共6页Journal of Liaoning University：Natural Sciences Edition

摘　　要：目的:对中国药典2015版第二部中单硝酸异山梨酯缓释片有关物质检查进行方法学验证.方法:采用高效液相色谱法,色谱柱:Diamonsil ODS-C18(250 mm×4.6 mm,5μm);流动相:甲醇-水(25∶75);检测波长:210 nm;柱温:40℃.结果:流动相不干扰测定.单硝酸异山梨酯、2-单硝酸异山梨酯和硝酸异山梨酯混合液在浓度范围1.5~12.5μg/m L内呈良好的线性相关性.方法精密度、重现性、专属性、样品溶液稳定性均良好.主药峰与杂质峰达到完全分离.结论:中国药典2015版第二部提出的方法简便、准确、专属性、重现性良好,可用于单硝酸异山梨酯缓释片有关物质的检查.Objective： Chinese Pharmacopoeia 2015 edition of the second part isosorbidedinitrate sustained-release tablets were related substances method validation. Methods： The HPLC method was carried out,the column： Diamonsil ODS-C18（ 250 mm × 4. 6 mm,5 μm）; mobile phase：methanol-water（ 25 ∶ 75）; detection wavelength： 210 nm. Results： The mobile phase does not interfere with the determination. Isosorbidedinitrate,2 isosorbidedinitrate and isosorbidedinitrate mixture in a concentration range of 1. 5 ~ 12. 5 μg/m L showed a good linear correlation. The method precision,reproducibility,specificity,sample solution stability were good. M ain drug peak and impurity peaks completely separated. Conclusion Chinese Pharmacopoeia 2015 edition of the second portion of the proposed method is simple,accurate,specific,reproducibility,and can be used for single-isosorbidemononitrate sustained release tablets checks related substances.

关 键 词：单硝酸异山梨酯 高效液相色谱 有关物质 

分 类 号：R917[医药卫生—药物分析学]