阿哌沙班中8种已知杂质的HPLC法定量检测

Quantitative determination of eight known kinds of impurities in Apixaban by HPLC

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 an HPLC method to determine eight kinds of impurities m Apixaban.Chromatographic column is Waters Xbridge Shield RP18 （150 mmx4.6 mm,5 μm）, acetonitrile-ammonium acetate solution is mobile phase, The column temperature is 40 ℃ and the flow velocityis 1.0 mldmin, The detection wavelength is 280 nm. Eight kinds of impurities in Apixaban wereseparated from the primary front effectively and the linearity range was 0.01-11 μg/mL. The averagerecovery rates of the eight impurities are 98.7%, 105.3%, 100.7%111.4%, 97.4%, 103.4%,98.9%, 97.6%, and the RSDs were 2.8%, 4.3%, 3.3%, 4.5%, 3.1%, 4.0%, 2.7%, 3.1%. Thismethod is simple, accurate and of good repeatability. It provides quality standards for erythromyeinapixaban.