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- Title
A VALIDATED METHOD FOR THE QUANTITATION OF PREGABALIN AND METHYLCOBALAMIN USING DIFFUSE REFLECTANCE FT-IR SPECTROSCOPY IN BULK AND COMBINED TABLET DOSAGE FORM.
- Authors
Dange, Shital S.; Kalyankar, Tukaram M.; Aadhav, Satish M.; Kowthalam, Anitha
- Abstract
A simple, accurate, precise and validated FTIR method was developed for the determination of pregabalin (PRG) and methylcobalamin (MCA) in bulk as well as in tablet dosage form. The drug was analyzed by FTIR spectrophotometer with DRIFT sampling technique. A wavenumber range 1660-1600 cm-1 (-COOH) and 3400-3250 cm-1(-CONH2) was 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 a 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 can be used for the estimation of both drugs in the combined dosage form.
- Subjects
ULTRAVIOLET spectrophotometry; REFLECTANCE spectroscopy; DOSAGE forms of drugs; FOURIER transform infrared spectrophotometers; PREGABALIN; DRUG dosage
- Publication
Indian Drugs, 2021, Vol 58, Issue 3, p54
- ISSN
0019-462X
- Publication type
Article