论文部分内容阅读
建立高效液相色谱法测定阿哌沙班中的8个已知杂质。色谱柱为Waters Xbridge Shield RP18(150mm×4.6mm,5μm);以乙腈-醋酸铵溶液为流动相,柱温:40℃,流量:1.0 m L/min,检测波长280 nm。阿哌沙班中8种杂质分离较好,与主峰均能有效分离,线性范围为0.01~11μg/m L;8种杂质的平均回收率分别为98.7%,105.3%,100.7%,111.4%,97.4%,103.4%,98.9%,97.6%,RSD分别为2.8%,4.3%,3.3%,4.5%,3.1%,4.0%,2.7%,3.1%。该法简便、准确、重复性好,可为阿哌沙班质量标准的制定提供参考。
To establish a HPLC method for the determination of 8 known impurities in apixaban. The column was Waters Xbridge Shield RP18 (150mm × 4.6mm, 5μm). The mobile phase was acetonitrile-ammonium acetate. The column temperature was 40 ℃, the flow rate was 1.0 mL / min and the detection wavelength was 280 nm. The eight impurities in apixaban were separated well and separated from the main peak. The linear range was 0.01-11 μg / m L. The average recoveries of eight impurities were 98.7%, 105.3%, 100.7% and 111.4%, respectively. 97.4%, 103.4%, 98.9% and 97.6% respectively. The RSDs were 2.8%, 4.3%, 3.3%, 4.5%, 3.1%, 4.0%, 2.7% and 3.1%, respectively. The method is simple, accurate and reproducible. It can provide a reference for the formulation of apixaban quality standards.