Novel RP-HPLC method for estimation of paracetamol and promethazine simultaneously in syrup formulation

Abstract

Paracetamol with Promethazine HCl is most popular over the counter drug which is used as antipyreticand antiemetic. A novel, simple, precise, less time consuming, economical and accurate reverse phase HPLC method hasbeen developed for their estimation using water, methanol and acetic acid in 79:20:1 v/v/v ratio as eluting phase onKromasil Silica column keeping flow rate at 1ml/min and detection at 249 nm. Both drugs observed linearity between10-50μg/ml and successfully resolved within 6 minutes (3.565 and 5.641 minutes for paracetamol and promethazinerespectively) with percent recovery between 98-101%. Tailing factor is within the range and number of theoretical platesis more than 2500. Method was validated as per ICH guidelines and the results indicate that these drugs could bequantified simultaneously without excipient interference and thus suitable for routine analysis of drugs in combination.