高效液相色谱法测定盐酸安罗替尼胶囊中主成分含量

Determination of Principal Component in Anlotinib Hydrochloride Capsules by HPLC

目的建立测定盐酸安罗替尼胶囊中主成分含量的高效液相色谱(HPLC)法。方法色谱柱为Waters SunFire C_(18)柱(250 mmÍ4.6 mm,5μm),流动相为甲醇-乙腈-25 mmol/L磷酸二氢钾(15∶30∶55,V/V/V),流速为1.0 mL/min,检测波长为242 nm,柱温为40℃,进样量为20μL。结果盐酸安罗替尼质量浓度在24.73~395.60μg/mL范围内与峰面积线性关系良好(r=0.9999,n=6);精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率为97.90%,RSD为1.17%(n=6)。结论该方法操作简单、出峰时间短、准确度高、重复性好,可用于盐酸安罗替尼胶囊主成分的含量测定。

Objective To establish a high-performance liquid chromatography(HPLC)method for determining the principal component in Anlotinib Hydrochloride Capsules.Methods The chromatographic column was Waters SunFire C_(18)column(250 mm×4.6 mm,5μm),the mobile phase was methanol-acetonitrile-25 mmol/L potassium dihydrogen phosphate(15∶30∶55,V/V/V),the flow rate was 1.0 mL/min,the detection wavelength was 242 nm,the column temperature was 40℃,and the injection volume was 20μL.Results The linear range of anlotinib hydrochloride was 24.73-395.60μg/mL(r=0.9999,n=6).The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rate of anlotinib hydrochloride was 97.90%,with an RSD of 1.17%(n=6).Conclusion This method is simple,fast,accurate and repeatable,which can be used for the determination of the main component of Anlotinib Hydrochloride Capsules.