Simultaneous quantification of five impurities in puerarin and its injections by HPLC method with correction factor

OBJECTIVE To establish a HPLC method with the relative correction factors (RCFs) for quantification of five critical related substances (A, B, C, D and E) in puerarin and its injection. METHOD Taking puerarin as the internal standard, corresponding RCFs of the critical related substances were determined respectively. According to their RCFs, simultaneous determination of five related substances in puerarin and its injection was performed. The method was evaluated by comparison the quantitative results of external standard method and the method with RCFs correction. RESULT There were no significant differences in the results of five critical related substances in 38 batches of puerarin and its injection by external standard method and the method with RCFs correction. CONCLUSION The HPLC method with RCFs was validated to be accurate and can be successfully applied to determine the critical related substances in puerarin and its injection.