Determination of Related Substances in Thanlidomide and in Its Tablets by HPLC Gradient Elution

OBJECTIVE To establish an HPLC method for determination of related substances of thanlidomide and its tab- lets.METHODS The RP-HPLC method was used.The separation was performed on Kromasil-column of C_(18) by gradient elution with mobile phases of A[CH_3CN-H_2O-H_3PO_4(17:83:0.1)]and B[CH_3CN-H_2O-H_3PO_4(27:73:0.1)];the column was maintainded at 25℃;the flow rate was 1 mL·min~(-1) and the detection wavelength was set at 218 nm.RESULTS Related substances and degrad- ed substances were completely separated from main eonstituent;single and total impurities were below the limits.CONCLUSION The method was selective,accurate,sensitive and it is suitable for determination of related substances in thanlidomide and its tablets.