ArticleA Simple Method Development and Validation for the Determination of Tolbutamide in Bulk and Marketed Dosage Form by UV - Spectrophotometric Technique
Dr. A. Madhukar * , Gariganti Swathi , Tanveer Fatima , Amina Fatima , Madhia Nikhat , Mohd Akram Mohsin ,
Dr. A. Madhukar *
The present work was to develop simple UV spectrophotometric methods for estimation of Tolbutamide (TOL) in bulk and tablet dosage form and validate as per ICH guidelines. In this method the absorption maxima was scanned from 200 – 400 nm and the λmax was found to be 248 nm was selected for analysis of Tolbutamide. Linearity was observed in the concentration range 1-12μg/ml (r2 =0.9992) for the method. The % assay for the marketed formulation for absorption maxima and area under the curve method was found to be 100.49% and 100.78% respectively. The methods were validated with respect to linearity, precision and accuracy studies. Recovery studies for absorption maxima, and area under the curve was found to be 99.52% and 100.64% respectively. The developed methods were validated for linearity, precision, accuracy, LOD and LOQ as per ICH guidelines. The method was found to be linear within the conc. Range of 1-12μg/ml for Tolbutamide. The present method was found to be simple, linear, precise, accurate and sensitive and can be used for routine quality control analysis for the estimation of Tolbutamide in bulk and tablet dosage form.
Tolbutamide (TOL), UV-Spectroscopy, Method Development, Validation and ICH guidelines.