A New Spectrophotometric Method for the Determination of Tianeptine in Tablets Using Ion-Pair Reagents

概要

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A new rapid and sensitive procedure assay is proposed for the spectrophotometric determination of tianeptine. The developed method involves formation of colored chloroform extractable ion-pair complexes of tianeptine with bromophenol blue (BPB), bromocresol green (BCG), bromothymol blue (BTB) and methyl orange (MO) in acidic medium. Beer's law is obeyed in the concentration ranges 3.0-12.0, 4.0-16.0, 4.0-14.0 and 2.0-10.0μg ml^<-1> with BPB, BCG, BTB and MO, respectively. The detection limit of tianeptine was found to be 1.8μg ml^<-1> for BPB, 2.0 for BCG, 2.0μg ml^<-1> for BTB and 1.0μg ml^<-1> for MO. Validation of the method was performed in terms of linearity, limit of detection (LOD), quantification (LOQ), accuracy and precision. Common excipients used as additives in pharmaceutical preparations do not interfere in the proposed method. The proposed method has been applied to determination of the examined drugs in pharmaceutical formulations and the results demonstrated that the method is equally accurate, precise, and reproducible as the official method. The t-test showed no significant difference at 95% confidence level.
公益社団法人日本薬学会の論文
2008-12-01