A SENSITIVE SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF PREGABALIN IN PURE DRUG AND PHARMACEUTICAL FORMULATIONS THROUGH BENZOYLATION

Abstract

Pregabalin is chemically related to an antiepileptic drug gabapentin. Chemical name of pregabalin is; (S)-3-isobutyl GABA, (S)-(+)-3-(aminomethyl)-5-methylhexanoic acid. It is an alpha2delta-ligand that has been found effective in a variety of animal models of neuropathic and nociceptive pain. It is found from IUPAC name that pregabalin does not have chromophoric group. To be UV sensitive, it is compulsory to have a chromophoric group in the structure. Thus, major aim of present research paper was to introduce a chromophoric group in pregabalin structure and make it UV sensitive. This was achieved by converting primary amine group of pregabalin in UV sensitive product through reaction with benzoyl chloride. A new sensitive and selective spectrophotometric method has been developed and validated according to ICH guidelines for determination of UV sensitive product of pregabalin in pure drug and pharmaceutical formulation. UV sensitive reaction product is determined at 223 nm using UV-VIS spectrophotometer. Developed method shows best results in terms of linearity, accuracy, precision, LOD and LOQ. It obeys Lambert-Beer’s law in the range of 2.5-12.5 $\mu$g mL, shows good linearity [r = 0.9997] and accuracy [99.71 % w/w]. The suggested procedure can be used for determination of pregabalin for pharmaceutical formulation. Thus, present research paper will be useful for routine analysis of pregabalin without need of sophisticated techniques.