New stability indicating RP-HPLC and Spectrophotometric methods for the determination of amoxapine in tablet dosage form

摘要

A simple, selective, linear, precise and accurate and validated stability indicating RP-HPLC method [M 1] and two spectrophotometric methods [M 2 & M 3] were developed for rapid assay of Amoxapine in tablet dosage form. In Method 1, a chromatographic system was employed with a Zodiac C18 column, a mobile phase of methanol(MeOH): acetonitrile(ACN): water in a proportion of 10:80:10 (v/v/v) and UV7000 Techcomp detector was used at a detection wavelength of 254nm. The forced degradation studies are carried as per ICH guidelines and a complete separation of the degradation peak with the drug peak was observed and hence is specific for the estimation of Amoxapine in the presence of its degradation products. The chromogenic reagents like 1,10 Phenanthroline (o-PHEN) (M 2) and Naphthaquinine sulfate (NQS) (M 3) were used in colour development for the estimation of amoxapine in pure and dosage forms. The methods were validated as per the ICH guidelines and adopted for the assay of Amoxapine in the bulk drug and formulations.