Abstract

UV- SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF BENFOTIAMINE IN BULK AND PHARMACEUTICAL DOSAGE FORMS

*Swaroopa H. M., Sagar G., Prajwal H. K., Sanjana S. and Jithin Jose A.

ABSTRACT

A simple, sensitive, accurate and precise Area under curve spectroscopy method was developed for the estimation of Benfotiamine in bulk and tablet dosage form. This method, involves the measurement of absorbances of Benfotiamine at the wavelength of 239-249 nm. 0.1 M HCl was used as solvent. Linearity was observed in the concentration range of 3-18 μg/ml with correlation coefficient 0.999. The method was validated for linearity, precision, accuracy, limit of detection, limit of quantitation and ruggedness. The accuracy of the method was confirmed by recovery studies of tablet dosage forms and was found to be 99.30%-100.51% for Benfotiamine. The method showed good reproducibility and recovery with % RSD less than 2.0. The limit of detection and limit of quantitation for estimation of Benfotiamine was found to be 0.122 μg/ml and 0.372 μg/ml. Thus the developed method was successfully applied for the estimation of Benfotiamine in pure and pharmaceutical dosage form.

Keywords: Benfotiamine, Area under curve Spectroscopy, 0.1MHCl, accuracy.