Development and validation of spectrophotometric method for determination of gabapentin in bulk and pharmaceutical dosage forms based on Schiff base formation with salicylaldehyde

doi:10.7324/japs.2019.90304

Abstract

Comparison of development methods based on UV/VIS spectrophotometry and ICP OES for the determination of iodine in pharmaceuticalsAmanda Ramos Della Fonte, Vitor de Araújo Freitas, Rosangela Cristina Barthus

Highlights

Gabapentin (GBP), chemically known as 1-(aminomethyl) cyclohexaneacetic acid (Fig. 1), has a molecular formula of C9H17NO2 and a molecular weight of 171.24 (USP 32, 2009)
A new, simple, sensitive, and accurate derivatization spectrophotometric method for the determination of GBP in pure form as well as in pharmaceutical formulations was developed in which, the use of salicylaldehyde (SA) as a derivatizing reagent for gabapentin was examined, for the first time, to produce a chromophore detectable by UV-Vis detector
Analytical method validation was performed according to the ICH guidelines (2005) with respect to accuracy, precision, specificity, linearity, limit of detection (LOD), and limit of quantitation (LOQ)

Summary

INTRODUCTION

Gabapentin (GBP), chemically known as 1-(aminomethyl) cyclohexaneacetic acid (Fig. 1), has a molecular formula of C9H17NO2 and a molecular weight of 171.24 (USP 32, 2009). GC (Borrey et al, 2005) and CE methods (Cao et al, 2012) reported for the GBP determination require long and tedious pretreatment of the samples and laborious clean up procedures prior to analysis. They are likely to be limited by routine availability of these techniques. A new, simple, sensitive, and accurate derivatization spectrophotometric method for the determination of GBP in pure form as well as in pharmaceutical formulations was developed in which, the use of salicylaldehyde (SA) as a derivatizing reagent for gabapentin was examined, for the first time, to produce a chromophore detectable by UV-Vis detector. The proposed method based on the formation of Schiff’s bases (imine compound) as a result of condensation reaction of primary amino group of GBP with active carbonyl group of SA in the presence of acetate solution in one-step reaction (Fig. 2), which did not require vigorous conditions, extraction, or any clean-up step prior to detection in comparing with other reported procedures (Ambala and Patel, 2011)

MATERIALS AND METHODS

Method validation

Result

RESULTS AND DISCUSSION

CONCLUSION