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

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 identi�ed and quanti�ed at a much lower concentration using chromatographic analysis such as HPLC. Methodology. �e 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. �e 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. �e developed method adapted derivatization of gabapentin using catechol reagent measured at λmax 300 nm. �e method used HPLC using mobile phase methanol water 50 : 50. �e eluted peak of the derivatized gabapentin was separated from other used derivatization reagents. �e analytical method showed to be a validated method, and all the tested validation parameters were within the accepted limits. �e 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∗10−6 mg/mL) and LOQ (1.5∗10−6 mg/mL). Conclusion. �e developed method is simple and feasible with high sensitivity and selectivity. It can be applied in the analysis of gabapentin in di�erent dosage forms and raw materials including active pharmaceutical ingredients (API). �is research work can be continued in the future, and the developed method can be used for testing gabapentin in biological systems.