A new Validated UV-visible Spectrophotometric Method for the Estimation of Pregabalin in its pure and dosage form using Bromophenol blue

Abstract

A new simple, accurate precise, cost effective, rapid and sensitive UV-Visible spectrophotometric method was developed for the estimation of Pregabalin in its pure and dosage form using Bromophenol blue. The developed method was validated as per ICH guideline in terms of linearity, accuracy, precision, ruggedness, LOD and LOQ. In this method the solvent used for the preparation of Pregabalin was distilled water. The method is based on the formation of brown colored ion-pair complex of Pregabalin with Bromophenol Blue reagent. The ion pair complex was produced in presence of Acid Phthalate Buffer of pH 3. The developed brown colour was stable at room temperature. The developed brown coloured complex showed maximum absorbance at 592nm. Linearity was found in the concentration range of 50, 60, 70, 80 and 90µg/ml with regression coefficient value 0.995. Precision studies for intra-day and inter-day shows that percentage relative standard deviation was within range of acceptable limit. The recovery studies were carried out at three percentage levels that is 50%, 100% and 150% levels. The results shows that the method was found to be accurate. The limit of detection (LOD) was found to be 10.91µg/ml and limit of quantification (LOQ) was found to be 33.06µg/ml. A ruggedness study was carried out using different analysts; assure that the method was rugged. Hence the method can be applied for routine quality control of the drug.