Stability-indicating HPLC-DAD methods for determination of two binary mixtures:Rabeprazole sodium-mo

来源 :Journal of Pharmaceutical Analysis | 被引量 : 0次 | 上传用户:cxddqqqqqq
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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. Two selective stability-IND HPLC methods are described for the determination of rabeprazole sodium (RZ) -mosapride citrate (MR) and RZ-itopride hydrochloride (IO) mixtures in the presence of their ICH-stress formed degradation products. Sequences were achieved on X- Bridge C18 column using two mobile phases: the first for RZ-MR mixture consisted of acetonitrile: 0.025 M KH 2 PO 4 solution: TEA (30: 69: 1 v / v; pH 7.0) : 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 The applications of the proposed HPLC methods indicated that the methods could be adopted to follow the stability of their formulations.
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