Development and Validation of HPLC Method for Estimation of Pregabalin in Bulk & Capsule Dosage Form Seema A * , Jeeja P and Ashish J University of Mumbai, Shri. D. D. Vispute College of Pharmacy & Research Centre, New Panvel, Navi Mumbai, India * Corresponding author: Seema A, Sect No. 15A, Plot No. 1, Flat No. C-003, New Panvel, Navi Mumbai, Maharashtra-410206, Tel: 8108213953/02227464448; E-mail: seemaauti.10@gmail.com Received date: May 24, 2016; Accepted date: Jun 22, 2016; Published date: Jun 25, 2016 Copyright: © 2016 Seema A, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract A simple, rapid, specific, precise and accurate HPLC method has been developed for the estimation of Pregabalin in bulk drugs and in capsule dosage forms. The mobile phase consisted of 80: 10: 10 (v/v/v) of Disodium Hydrogen Phosphate Buffer: Acetonitrile: Methanol. The flow rate is 1 ml/min. Chromatographic determination of Pregabalin was performed on Inertsil ODS -3V, C18 (250 X 4.6 mm Id, 5μm) column. The wavelength of detection is 210 nm. The injection volume is 20μL. The retention time of Pregabalin is 4.7 minutes. The developed method was validated in terms of specificity, accuracy, precision, linearity, solution stability, ruggedness, robustness and system suitability. The influence of Acid, Alkaline, Oxidative Stress, Photolytic stress, Thermal stress, and Humidity stress conditions on pregabalin was studied. Results indicated that Pregabalin is stable under the experimental conditions. The proposed method has been successfully used for the routine analysis of pregabalin in capsule dosage forms. Keywords: HPLC; Pregabalin; Estimation; Bulk drug; Capsule dosage form Introduction Pregabalin [1] chemically known as (S)-2(amino methyl)-5-methyl hexanoicacid (Figure 1), is a white crystalline solid, which is soluble in water and in both basic and acidic aqueous solution sand used as anticonvulsant, analgesic medication and neurotransmitter. [2,3] Pregabalin is the 3 isobutyl substituted analogue of δ amino butyric acid (GABA) but is inactive at GABA receptors. [4] Tis drug produces its actions by binding to the alpha 2 delta (α2δ) subunit of the voltage gated calcium channels. It is well absorbed afer oral administration and largely excreted by renal excretion [5] (Figure 1). Figure 1: Structure of Pregabalin. It was designed as a more potent successor to gabapentin. Pregabalin and gabapentin bind with high afnity to α2δ protein, an auxiliary subunit of Q type voltage sensitive calcium channels in the peripheral and central nervous system. [6] Binding to α2δ protein, results in calcium infux reduction at nerve terminals which leads to reduction of neurotransmitters such as glutamate and noradrenaline and abnormal neuronal excitability. [7,8] Pregabalin is thought to be useful for treating any other conditions, pain, physiological conditions associated with psychomotor stimulants, infammation, gastrointestinal damage, alcoholism, insomnia, and various psychiatric disorders, including mania and bipolar disorder [9]. Pregabalin approved for a number of indications in the US and Europe that include adjunctive therapy of partial seizures in adults, pain from diabetic neuropathy or post-herpetic neuralgia in adults, and the treatment of anxiety disorders. [10] It received U.S.FDA approval for use in treating neuropathy pain and post herpetic neuralgia in 2004, appeared on the U.S market in fall 2005. [11] Recent studies have shown that pregabalin is efective at treating chronic pain in disorders such as fbromyalgia [12] and spinal card injury. [13] It is consider having a low potential for abuse, and a limited dependence liability if missed, and is thus classifed as a schedule V drug in the U.S [14]. Although various bio analytical methods for estimation of pregabalin in human serum [15] and spectrophotometric method for estimation of pregabalin in dosage form [16,17] have been reported in the literature. Recently a new validated HPLC method [18] was developed for determination of pregabalin in bulk drug and capsule dosage forms. All of these methods are very expensive because these methods require long and tedious pre-treatment of the samples, laborious clean up procedures and derivatization for the analysis of pregabalin. It requires simple new HPLC method for analysis of pregabalin in bulk and the determination of pregabalin in capsules. So the attempt was made to develop a simple, efcient and selective method for the analysis of pregabalin in bulk and the determination of pregabalin in capsules. Te UV detection, which is readily available in most analytical and pharmaceutical laboratories, was used for HPLC instrumentation. Te developed method was validated according to the International Conference on Harmonization (ICH) guidelines. Seema A, Pharm Anal Acta 2016, 7:6 DOI: 10.4172/2153-2435.1000492 Research Article Open Access Pharm Anal Acta ISSN:2153-2435 PAA an open access journal Volume 7 • Issue 6 • 1000492 P h a r m a c e u t i c a A n a l y t i c a A c t a ISSN: 2153-2435 Pharmaceutica Analytica Acta