ICH guideline

To method develop and validate simple, rapid, cost effective, linear, accurate, precise and economical for the simultaneous estimation of Pregabalin and Methylcobalamin in bulk and tablet dosage form by using UV-Spectrophotometry. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV-Spectroscopic method was developed for estimation of Pregabalin and Methylcobalamin in bulk and tablet dosage form and also validated as per ICH guidelines. The method based on measurement of absorbance at two wavelengths 222 nm (λmax of Pregabalin) and 219 nm (λmax of Methylcobalamin) in Ethanol and distilled water. Linearity graph of Pregabalin and Methylcobalamin were found to be linear in the concentration ranges of 30-150 μg/ml and 0.6-3 μg/ml, respectively, with their correlation coefficient values (R2) 0.999. The low %RSD values indicate method to be accurate and precise. The % recovery of tablets found to be in range of 97-102% and other validation parameter were found to be within the limits as per ICH guidelines.