Determination of Principal Component in Anlotinib Hydrochloride Capsules by HPLC
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 C18 column(250 mm×4.6 mm,5 μm),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 20 μL.Results The linear range of anlotinib hydrochloride was 24.73-395.60 μg/mL(r=0.999 9,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.
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