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:0.025 M KH_2PO_4solution: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 283 nm.The two methods were validated and validation acceptance criteria were met in all cases.Peak purity testing using contrast angle theory,relative absorbancc and log A versus the wavelengths plots were presented.The%recoveries of the intact drugs were between 99.1%and102.2%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.