Stability-indicating HPLC–DAD methods for determination of two binary mixtures: Rabeprazole sodium–mosapride citrate and rabeprazole sodium–itopride hydrochloride

摘要

Two selective stability-indicating HPLC methods are described for determination of rabeprazole sodium (RZ)–mosapride citrate (MR) and RZ–itopride hydrochloride (IO) mixtures in the presence of their ICH-stress formed degradation products. Separations were achieved on X-Bridge C18 column using two mobile phases: the first for RZ–MR mixture consisted of acetonitrile: 0.025M KH 2 PO 4 solution: TEA (30:69:1 v/v; pH 7.0); the second for RZ–IO mixture was at ratio of 25:74:1 (v/v; pH 9.25). The detection wavelength was 283nm. The two methods were validated and validation acceptance criteria were met in all cases. Peak purity testing using contrast angle theory, relative absorbance and log A versus the wavelengths plots were presented. The % recoveries of the intact drugs were between 99.1% and 102.2% with RSD% values less than 1.6%. Application of the proposed HPLC methods indicated that the methods could be adopted to follow the stability of their formulations.