Determination of the Related Substances in Erlotinib Hydrochloride Bulk Drug and Tablets by Supercritical Fluid Chromatography
A supercritical fluid chromatography(SFC)method was established for the separation and determination of erlotinib hydrochloride(1)and its four related substances.A Torus 2-PIC column(3.0 mm×100 mm,1.7 μm)was used with the mobile phase containing a mixture of supercritical CO2 and methanol by gradient elution.The injection volume was 1 μL,the column temperature was 50 ℃,and the flow rate was 1.0 mL/min.The results showed that each compound peaked and was completely separated within 7 minutes.And it was linear for four related substances and 1 in the ranges of 0.5-40,2-60,0.4-40,0.5-40,5-100 μg/mL,respectively.The LODs of 1 and impurities A,B,C,D were 0.2,0.2,0.5,0.1,0.2 μg/mL,respectively,and the LOQs were 0.5,0.5,2.0,0.4,0.5 μg/mL,respectively.The recoveries(n=3)of four related substances were between 96.0％and 104.2％,with RSDs all less than 3.0％.The established method is rapid,effective,highly sensitive,environmentally friendly,which can be effectively used for quality control of 1 bulk drug and tablets.
万方数据
维普
