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

• Published in: Journal of pharmaceutical analysis 2014-08, Vol.4 (4), p.258-269
• Main Authors: El-Fatatry, Hamed M., Mabrouk, Mokhtar M., Hewala, Ismail I., Emam, Ehab H.
• Format: Article
• Language: English
• Subjects: HPLC-DAD; HPLC方法; Itopride hydrochloride; Mosapride citrate; Original; Peak purity; Rabeprazole sodium; Stability-indicating HPLC–DAD; 二元混合物; 枸橼酸莫沙必利; 测定; 盐酸; 稳定性; 钠
• ISSN: 2095-1779; 2214-0883
• DOI: 10.1016/j.jpha.2013.09.009

Two selective stability-indicating HPLC methods are described for determination of rabeprazole sodium （RZ）-mosapride citrate （MR） and RZ-itopride hydrochloride （IO） mixturcs in the presence of their ICH-stress formed degradation products. Separations were achieved on X-Bridge CI 8 column using two mobile phases： the first for RZ-MR mixture consisted of acetonitrile： 0.（125 M KH,PO4 solution： TEA （30：69：1 v/v; pH 7.0）; the second for RZ-IO mixture was at ratio of 25：74：1 Iv/v： pH 9.25J. The detection wavelength was 283 nm. The two methods were validated and wdidation 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.