DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING HPLC METHOD FOR THE ESTIMATION OF RABEPRAZOLE IMPURITIES IN PHARMACEUTICAL DOSAGE FORMS BY DESIGN OF EXPERIMENTS

摘要

A novel stability-indicating reverse phase liquid chromatographic method was developed for the determination of Rabeprazole impurities in Rabeprazole tablet formulations. One unknown impurity was isolated and characterized by using MS and NMR, which was formed in the formulated drug stability study. Rabeprazole was subjected to the stress conditions like oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Chromatographic separation was achieved on HPLC in gradient elution mode by QbD-approach. The eluted compounds were monitored at 280 nm. All the impurities and degradation products were well resolved from the main peak, proving the stability-indicating power of the method. On the basis of spectral data, the unknown impurity was characterized as 1-(1H -Benzimidazol-2-yl)-4-(3-methoxypropoxy)-3-methylpyridinium-2-carboxylate. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and ruggedness