Determination of related substances in the raw materials of novel GnRH antagonist LPM7100328 by HPLC
Objective To establish an HPLC method for the determination of related substances in the raw drug substance of novel gonadotropin-releasing hormone(GnRH)antagonist LPM7100328.Methods An ACE Excel Super C18(4.6 mm×150 mm,3 µm)column was used.The mobile phase A consisted of 0.01 mol·L-1 potassium dihydrogen phosphate aqueous solution(adjusting pH to 2.5 with phosphoric acid),while acetonitrile-methanol(80∶20)was used as the mobile phase B,with gradient elution at a flow rate of 1.0 mL·min-1.The detection wavelength was 248 nm,and the column temperature was 40℃.Results The peaks of LPM7100328 and each impurity were well separated,with good linearity in the linear self-concentration range.The detection limits for LPM7100328,and impurities A,B,and C were 0.0746,0.0714,0.0740,and 0.0741 μg·mL-1,respectively.Conclusion The method is specific,sensitive and accurate,which is suitable for the determination of related substances in LPM7100328,and can provide a reference for subsequent study and quality control of LPM7100328.
万方数据
维普
