Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF GABAPENTIN IN FORMULATION BY UV VISIBLE SPECTROPHOTOMETRY

K. Swaroopa Rani*, K. T. Lahari Priyanka, K. Y. Usha Sri, P. Gayathri, P. Alekya, S. Mojesh and T. Pallavi Priya

ABSTRACT

Two simple, sensitive and reproducible analytical methods have been developed based on UV-Visible spectrophotometric analysis for the estimation of GABAPENTIN and its pharmaceutical formulation, followed by validation of the optimized method by using ICH guidelines. Two new methods, method A was developed based on reaction of bromocresol green reagent with carboxylic acid functional group in gabapentin having maximum absorbance (λmax) at 614. Method B was developed based on reaction with NQS reagent with primary amine in gabapentin with maximum absorbance (λmax) at 362. Beers law was obeyed in the range of 0.4 to 1μg/ml for method A and for method B 0.1 to 1μg/ml. The validity of the described procedures was assessed. Statistical analysis of the results has been carried out revealing high accuracy and good precision. The molar absorptivity, limits of detection (LOD) and limit of quantification (LOQ) and sandell`s sensitivity are also reported. The reliability of the proposed methods was further established by parallel determination by reference method and also by recovery studies.

Keywords: Gabapentin, Bromocresol green, NQS reagent, UV Visible Spectrophotometer.