Gabapentin merupakan obat antikonvulsan baru yang memiliki struktur analog dengan γ-amino butyric acid (GABA). Gabapentin bekerja dengan menghambat uptake kalsium pada kanal kalsium presinaps di otak. Penelitian ini bertujuan untuk mengembangkan dan memvalidasi suatu metode HPLC menggunakan detektor UV untuk menetapkan kadar gabapentin dalam kapsul. Metode ini didasarkan atas reaksi antara gabapentin dengan 1-fluoro-2,4- dinitrobenzen (FDNB) dalam asetonitril yang terjadi dengan adanya dapar borat (pH 9,5) pada temperatur 65oC selama 20 menit, yang menghasilkan produk berwarna kuning dengan serapan maksimum pada 367 nm. Pemisahan dilakukan secara HPLC dengan fase diam kolom Zorbax ODS (Agilent) (250 x 4,6 mm, 5 μm) dan fase gerak dapar asetat 50 mM pH 3,7 : metanol : asetonitril (25 : 30 : 45 v/v/v) dengan laju alir 0,8 mL/menit, serta deteksi UV pada 367 nm.p Metode ini divalidasi terhadap parameter-parameter ketepatan (akurasi), ketelitian (presisi), linearitas, selektivitas, LOD dan LOQ, dan diperoleh hasil memenuhi persyaratan validasi. Aplikasi metode HPLC setelah divalidasi tersebut pada penetapan kadar gabapentin dalam kapsul menghasilkan LOD = 1,05 μg/mL dan LOQ = 3,49 μg/mL, rentang linearitas 3,49 - 100 μg/mL dengan koefisien korelasi 0,99996 dan rentang rekoverinya 97,27 – 104,24% (%RSD = 2,63%).

Gabapentine, is a new antiepileptic drug which has a structural analogue of neurotransmitter γ-aminobutyric acid (GABA). Gabapentine inhibits calcium uptake of gated calcium channels presinaps in the brain. This research aimed to develop and validate a new HPLC method with UV detection for determination of gabapentine in capsule. The method is based on the reaction of gabapentine with 1-fluoro-2,4- dinitrobenzen (FDNB) in acetonitrile which carried out in the presence of borate buffer (pH = 9,5) at 65oC for 20 minutes, which formed a yellow colored product with the absorption at 367 nm. The product was separated by HPLC using A Zorbax ODS (Agilent) column (250 x 4.6 mm, 5 μm) was utilized as stationary phase and 50 mM acetate buffer (pH 3.7) : methanol : acetonitril (25 : 30 : 45 v/v/v) as mobile phase, with flow rate 0.8 mL/min, and the detection at 367 nm. The purposed method was validated by means of accuracy, precision, linearity, selectivity, LOD and LOQ, and the complied with the requirement for validity. The method has been succesfully applied for the determination of gabapentine in capsule with LOD = 1.05 μg/mL and LOQ = 3.49, linear quantitative response curve was generated over a concentration range of 3.49 - 100 μg/mL with the correlation coefficient of 0.99996 and recovery range of 97.27 – 104.24% with RSD 2.63%.

Kata Kunci : gabapentin, FDNB, HPLC, validasi