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目的建立单硝酸异山梨酯阿司匹林缓释片中两主药成分含量测定的反相高效液相色谱法方法。方法采用反相高效液相色谱法。色谱条件:色谱柱:Agilent ZOBAX SB-C_(18)(4.6 mm×250 mm,5μm);流动相:流动相:甲醇-0.1%二乙胺水溶液-冰醋酸(40:60:4);柱温:30℃;流速:1.0 ml/min;检测波长:235 nm;进样量:20μl。结果在选定色谱条件下单硝酸异山梨酯阿司匹林缓释片中辅料对两主药无干扰,单硝酸异山梨酯和阿司匹林分别在12~60μg/ml内、15~75μg/ml内,峰面积与浓度线性关系良好,相关系数分别为r=0.9999(n=5)、r=0.9999(n=5);平均回收率依次为99.90%、100.02%,相对标准偏差(RSD)依次为0.02%、0.32%;重复性试验RSD依次为0.06%(n=6)、0.27%(n=6)。结论本方法简便,准确可靠,专属性强,可用于单硝酸异山梨酯阿司匹林缓释片的含量测定。
OBJECTIVE To establish an RP-HPLC method for the determination of two main constituents in isosorbide mononitrate sustained-release tablets. Methods Using reversed-phase high performance liquid chromatography. The chromatographic conditions were as follows: column: Agilent ZOBAX SB-C 18 (4.6 mm × 250 mm, 5 μm); mobile phase: mobile phase of methanol-0.1% aqueous diethylamine solution-glacial acetic acid Temperature: 30 ° C; Flow rate: 1.0 ml / min; Detection wavelength: 235 nm; Injection volume: 20 μl. Results In the selected chromatographic conditions isosorbide mononitrate aspirin sustained-release tablets in the two main drugs without interference accessories, isosorbide mononitrate and aspirin were 12 ~ 60μg / ml, 15 ~ 75μg / ml, the peak area (R = 0.9999, n = 5). The average recoveries were 99.90% and 100.02%, respectively. The relative standard deviations (RSDs) were 0.02% 0.32%; RSD repeatability test was 0.06% (n = 6), 0.27% (n = 6). Conclusion The method is simple, accurate, reliable and specific. It can be used for the determination of isosorbide mononitrate aspirin sustained-release tablets.