A VALIDATED METHOD FOR QUANTITATION OF PREGABALIN AND METHYLCOBALAMIN USING DIFF USE REFLECTANCE FTIR SPECTROSCOPY IN BULK AND COMBINED TABLET DOSAGE FORM

A Simple, accurate precise and validated FTIR method was developed for the determination ofpregabalin (PRG) and methylcobalamin (MCA) in bulk as well as in tablet dosage form. The drug was analyzed by FTIR spectrophotometry with DRIFT sampling technique. wavenumber ranges 1660-1600 cm-1 (-COOH) and3400-3250 cm−1(-CONH2) were selected for pregabalin and methylcobalamin, respectively. The method was found to be linear over the range of PRG 1–6% w/w and MCA 0.2–1.2% w/w with good regression coefficient (r2) of PRG 0.9960 and MCA 0.9976. The percent recovery of pregabalin and methylcobalamin in marketed tablet dosage form was in the range of 98.25 – 99.00% and 98.62 – 99.60%, respectively. The LOD & LOQ were found 1.4003 & 4.2434 of PRG and 0.2027 & 0.6142 of MCA, respectively.The developed FTIR method was validated as per ICH guidelines and it can be used for the estimation of both drugs in combined dosage form.