Quantitative Analysis of Irbesartan in Pharmaceutical Formulation Using MBTH Reagent

A novel, simple, sensitive and efficient method has been established for the quantification of Irbesartan in bulk and pharmaceutical formulations utilizing the MBTH reagent. The objective of this analytical validation approach is to substantiate its efficacy by laboratory trials, demonstrating that the method satisfies the requisite minimal requirements for laboratory application. 3-methyl-2-benzothiazoline hydrazone interacts with the secondary amine group of Irbesartan in the presence of the oxidizing agent cerric ammonium sulphate. The resultant blue chromogen, when analysed spectrophotometrically in the visible spectrum (400 nm-800 nm), exhibits a peak absorbance at 656 nm. This approach can be effectively utilized for quantifying drug content in pharmaceutical formulations. The analysis results have been statistically confirmed. A coefficient of determination (r²) of 0.999 indicated adherence to Beer-Lambert's law across the concentration range of 2 to10 μg/mL. The limit of quantification and limit of detection limits were determined to be 1.2 μg/mL and 0.39 μg/mL, respectively. Keywords Irbesartan; Spectrophotometrically; MBTH reagent; Validation