Development and Validation of Ninhydrin Based Colorimetric Spectrophotometric Assay for Determination of Pregabalin in Different Dissolution Mediums

Abstract

A simple, accurate, cheap and quick spectrophotometric method was developed for the estimation of
pregabalin in pharmaceutical pure and dosage forms. Three different mediums (Distilled water, 0.1 N
HCl with pH 1.2, buffer with pH 6.8) were taken. The method was developed based on the reaction of
ninhydrin with the primary amine present in pregabalin. In all the three cases, reaction produces
Rheumann’s Purple colour and absorbs at 571, 555 and 569 nm in distilled water, 0.1 N HCl and pH
6.8 respectively. Beer’s law was followed in the concentration range of 100-200 µg mL-1 in phosphate
buffer with pH 6.8, 50-100 µg mL-1 in pH 1.2 and 10-100 µg mL-1 in distilled water. The method
developed was successfully applied to pharmaceutical dosage forms with good efficacy and recovery
was found from 98.41-99.53%. The method seems to be simple, less time consuming, cost effective
and accurate for estimation of pregabalin in pharmaceutical pure and dosage forms.