HPLC Analytical Method Development and Validation of Gabapentin through Chemical Derivatization with Catechol as a Chromophore

Abstract

Background. Gabapentin is a drug with anticonvulsant activity and has been widely used in the treatment of epilepsy. Gabapentin chemical structure lacks a chromophore which makes its absorption very low and hence complicates its analysis and reduces the sensitivity of the method. Adding a chromophore by chemical derivatization makes the drug easily identified and quantified at a much lower concentration using chromatographic analysis such as HPLC. Methodology. The derivatization of gabapentin was done by adding a chromophore to the structure by introducing an auxochrome group. Suitable coupling reagents were used to introduce catechol group to gabapentin. The analytical method has been developed using HPLC with UV/Vis detector. Moreover, the method was validated for parameters such as linearity, range, precision, accuracy, LOD, and LOQ. Result. The developed method adapted derivatization of gabapentin using catechol reagent measured at λmax 300 nm. The method used HPLC using mobile phase methanol water 50 : 50. The eluted peak of the derivatized gabapentin was separated from other used derivatization reagents. The analytical method showed to be a validated method, and all the tested validation parameters were within the accepted limits. The developed method was found to be linear (R2 = 0.9917), precise (RSD = 0.91) and accurate (% recovery = 105). Moreover, the developed method was sensitive with LOD (0.5 ${}^{\ast }$ 10−6 mg/mL) and LOQ (1.5 ${}^{\ast }$ 10−6 mg/mL). Conclusion. The developed method is simple and feasible with high sensitivity and selectivity. It can be applied in the analysis of gabapentin in different dosage forms and raw materials including active pharmaceutical ingredients (API). This research work can be continued in the future, and the developed method can be used for testing gabapentin in biological systems.