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.
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