Quantitative Analysis of Rabeprazole Sodium in Commercial Dosage Forms by Spectrophotometry

概要

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The main aim of this work is to develop and validate two spectrophotometric methods for the quantitative analysis of rabeprazole sodium in commercial dosage forms. Method A is based on the reaction of drug with 3-methyl-2-benzothiazolinone hydrazone hydrochloride (MBTH) in the presence of ammonium cerium(IV) nitrate in acetic acid medium at room temperature to form red-brown product which absorbs maximally at 470nm. Method B utilizes the reaction of rabeprazole sodium with 1-chloro-2,4-dinitrobenzene (CDNB) in dimethyl sulfoxide (DMSO) at 45±1℃ to form yellow colored Meisenheimer complex. The colored complex has a characteristic band peaking at 420nm. Under the optimized reaction conditions, proposed methods are validated as per ICH guidelines. Beer's law is obeyed in the concentration ranges of 14-140 and 7.5-165μg ml^<-1> with linear regression equations of A=6.041×10^<-4>+1.07×10^<-2>C and A=1.020×10^<-3>+5.0×10^<-3>C for methods A and B, respectively. The limits of detection for methods A and B are 1.38 and 0.75μgml^<-1>, respectively. Both methods have been applied successfully for the estimation of rabeprazole sodium in commercial dosage forms. The results are compared with the reference UV spectrophotometric method.
公益社団法人日本薬学会の論文
2008-07-01