Abstract

DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF PREGABALIN USING NINHYDRIN AND ASCORBIC ACID

Regina Andayani*, Supina and Friardi

ABSTRACT

Pregabalin is an antiepileptic drug used for neuropathic pain. This study aimed to develop and validate the UV-visible spectrophotometric method for the determination of pregabalin in capsules. The analytical method was determined using the condensation reaction between pregabalin and ninhydrin-ascorbic acid in a citrate buffer pH 5. The pregabalin-ninhydrin complex was dark blue with a maximum wavelength of 568 nm. This product was assayed to evaluate the drug content in the formulation quantitatively. The calibration curve showed to be linear in the concentration range of 4-12 μg/mL with a detection limit of 0.35μg/mL and a quantitation limit of 1.19 μg/mL. The precision was assessed by determining the intra-day and inter-day precision which ranged between 0.28 – 0.82% and 0.71 – 1.13% respectively. The recovery values ranged from 99.31 ± 0.14%. These results showed that the newly developed method was simple, sensitive, accurate, and effective in determining pregabalin in capsules.

Keywords: validation method, UV-visible Spectrophotometry, Pregabalin, Ninhydrin, Ascorbic acid.