Determination of Pregabalin in Bulk Drug and Pharmaceutical Formulations using Validated Stability-indicating Spectrophotometric Methods

Abstract

The present study describes the development and subsequent validation of stabilityindicating, accurate, reliable, and sensitive spectro-photometric methods for the determination of Pregabalin in presence of its degradation products, including Dual wavelength and Ratio derivative after derivatization with vanillin reagent. With the Dual wavelength technique, Pregabalin could be determined in the range of 40-160 μg/mL at 390nm and 395.8nm. With the Ratio derivative technique, it could be determined in the above ranges at 401.6nm. All the methods were validated according to the International Conference on Harmonization guidelines and successfully applied to determine Pregabalin in pure form, laboratory-prepared mixtures, and pharmaceutical formulation. The obtained results were statistically compared with reported methods of analysis and there were no significant differences with respect to accuracy and precision of the adopted techniques.