Abstract

“STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF PALIPERIDONE AND IT’S PHARMACEUTICAL DOSAGE FORM.”

Snehal B. Ghanwat*, Rajendra B. Patil and Rushiraj Gaikwad

ABSTRACT

Paliperidone is a atypical neuroleptic agent. A precise, accurate, linear and sensitive spectrophotometric method for the determination of Paliperidone in pharmaceutical tablet dosage forms has been developed. The Paliperidone absorption maxima were monitored at 237.4 nm with UV detection. Beer’s law obeyed for Paliperidone drug and these method was linear (r2=0.999) at concentration range from 5-25μg/mL. Precise (RSD, interday, intraday precision not more than 1%), accurate, specific and robust. The result showed that the proposed method can be successfully applied for the determination of Paliperidone in dosage forms. The method was validated for various parameters as per ICH guidelines. The drug was subjected to stress condition of hydrolysis (acidic, alkaline and neutral), oxidation, photolysis and thermal degradation.

Keywords: Paliperidone, Spectrophotometer, Validation, ICH guidelines, Stability.