DEVELOPMENT AND VALIDATION OF HPTLC METHODS FOR SIMULTANEOUS ESTIMATION OF GABAPENTIN AND AMITRIPTYLINE HYDROCHLORIDE IN ITS MARKETED FORMULATION

Abstract

A simple, selective, linear, precise, and accurate HPTLC method was developed and validated for the simultaneous estimation of Gabapentin & Amitriptyline hydrochloride.HPTLC method was developed using stationary phase pre-coated silica gel G60 – F₂₅₄ aluminium sheet and Methanol: acetonitrile: ethyl acetate: ammonia (5:3:2:0.1) as a mobile phase. In HPTLC method, the method was found to be linear in the range of 1200-2400 ng/band for GABA and 40-80 ng/band for AMI. R_f value obtained was 0.35 for Gabapentin and 0.55 Amitriptyline Hydrochloride. The developed method was validated as per ICH guidelines Q2 (R1). The proposed HPTLC method is accurate, precise, sensitive, selective and rapid and can be used for the routine simultaneous estimation of Gabapentin and Amitriptyline Hydrochloride in combination.