Abstract

A new stability-indicating specific and accurate HPLC method for determination of process-related impurities in bulk and formulation samples of quetiapine hemifumarate:An antipsychotic drug

Author(s): Vijayavitthal T.Mathad, Sanjay A.Jadhav, Shashikant B.Landge, Sonali L.Jadhav,Navanath C.Niphade, Saroj R.Bembalkar

A simple reversed-phase liquid chromatographic method was developed for the related substances determination in quetiapine hemifumarate, an antipsychotic drug. Forced degradation studies were performed on bulk sample of quetiapine hemifumarate using acid, base, oxidative hydrolysis, thermal stress and photolytic degradation. Considerable degradation of the drug substance was observed during oxidative and acid hydrolysis. The chromatographic method was fine tuned using the samples generated from forced degradation studies and eight process related impurities (Imp-1 to Imp-8). Good resolution between the peaks corresponds to synthetic impurities and degradation products from the analyte were achieved on Zorbax eclipsed XDB C18 column. The stressed test solutionswere assayed against the qualified working standard of quetiapine hemifumarate and the mass balance in each case was close to 99.9%, indicating that the developed method was stability-indicating. Validation of the developed method was carried out as per ICH requirements. The proposed RP-HPLC method was successfully applied for the routine evaluation of the quality of bulk drug samples and detection of impurities in pharmaceutical formulations.