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目的采用HPLC法测定新型抗三阴性乳腺癌(TNBC)药物ZCH646原料药的含量,并考察其稳定性。方法色谱柱为Phenomenex Gemini C18(150 mm×4.6 mm,5μm),流动相为10 mmol·L-1乙酸铵缓冲盐-乙腈(45∶55,三乙胺调p H9.0),检测波长272.4 nm,流速1.0 m L·min-1,柱温25℃。结果 ZCH646能与相邻杂质完全分离,1~100μg·m L-1ZCH646与峰面积的线性关系良好(r=0.9995),检测限为20 ng·m L-1;低、中、高浓度的平均回收率和RSD分别为100.1%、99.7%、101.6%和0.81%、0.51%、1.24%;ZCH646在高温、高湿条件下稳定,强光照射条件下颜色略有变化。结论所用方法简便快速、专属性强、精密度高,适用于ZCH646的含量测定和稳定性研究。
OBJECTIVE To determine the content of ZCH646 drug substance of new anti-triple-negative breast cancer (TNBC) drug by HPLC and investigate its stability. Methods Phenomenex Gemini C18 (150 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of 10 mmol·L -1 ammonium acetate buffer (45:55) and triethylamine adjusted pH9.0. The detection wavelength was 272.4 nm, flow rate 1.0 m L · min-1, column temperature 25 ℃. The results showed that ZCH646 could be separated completely from the adjacent impurities. The linear relationship of 1 ~ 100μg · m L-1ZCH646 with the peak area was good (r = 0.9995) and the detection limit was 20 ng · m L-1. The recoveries and RSDs were 100.1%, 99.7%, 101.6% and 0.81%, 0.51% and 1.24%, respectively. The color of ZCH646 was stable under high temperature and high humidity. Conclusion The method is simple, rapid, specific and precise, suitable for the determination of ZCH646 and stability studies.