Development and Validation of UV Spectrophotometric Method for Estimation of Benfotiamine in Bulk and Dosage Form

A simple, rapid, precise and economical spectrophotometric method has been developed for quantitative analysis of Benfotiamine (BEN) in Pharmaceutical formulations. The method is developed using water as a solvent. The stock solution of BEN was prepared in water and small quantity of conc. HCl was added to dissolve the drug completely. Subsequent dilution has been done in water. The standard solution of BEN showed absorption maxima at 245 nm.

The drug obeyed Beer-Lambert's law in the concentration range of 4-24 μg/mL with Regression coefficient 0.9990 at 245 nm. The overall % recovery was found to be 99.72 at 245, which reflect that the method is free from interference of the impurities and other additives used in tablet formulation. Relative standard deviations of absorbance from six measurements was always found to be less than 2%. The results of analysis have been validated as per ICH (Q1B, 1996, Q2 R1, 1996) guidelines. The wavelength can be adopted in routine spectroscopic analysis of BEN in tablet dosage form.