El-Fatatry Hamed M, Mabrouk Mokhtar M, Hewala Ismail I, Emam Ehab H
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Tanta, Tanta, Egypt.
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, Egypt.
J Pharm Anal. 2014 Aug;4(4):258-269. doi: 10.1016/j.jpha.2013.09.009. Epub 2013 Sep 23.
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 KHPO 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 283 nm. 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 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.
本文描述了两种选择性稳定性指示高效液相色谱法，用于在存在国际协调会议（ICH）规定的应激条件下形成的降解产物的情况下，测定雷贝拉唑钠（RZ）-枸橼酸莫沙必利（MR）和RZ-盐酸伊托必利（IO）混合物。使用两种流动相在X-Bridge C18柱上实现分离：第一种用于RZ-MR混合物，由乙腈：0.025M磷酸二氢钾溶液：三乙胺（30:69:1 v/v；pH 7.0）组成；第二种用于RZ-IO混合物，比例为25:74:1（v/v；pH 9.25）。检测波长为283nm。两种方法均经过验证，且在所有情况下均符合验证接受标准。展示了使用对比角理论、相对吸光度以及对数与波长关系图进行的峰纯度测试。完整药物的回收率在99.1%至102.2%之间，相对标准偏差（RSD%）值小于1.6%。所提出的高效液相色谱法的应用表明，这些方法可用于跟踪其制剂的稳定性。
Zotero 插件
