Int. J. Pharm. Sci. Rev. Res., 75(1), July - August 2022; Article No. 23, Pages: 133-138 ISSN 0976 – 044X International Journal of Pharmaceutical Sciences Review and Research Available online at www.globalresearchonline.net ©Copyright protected. Unauthorised republication, reproduction, distribution, dissemination and copying of this document in whole or in part is strictly prohibited. 133 Shahnaz Usman* 1 , Hemant KS Yadav 1 , Sakina Fatima 2 , Anab Usman 3 , Kashif Ali Safdar 4 1 Department of Pharmaceutics, RAK College of Pharmacy, RAK Medical and Health Sciences University, Ras Al Khaimah, United Arab Emirates. 2 Department of Pharmaceutics, Institute of Pharmaceutical Sciences, Jinnah Sindh Medical University, Karachi, Pakistan. 3 Department of Medicine, Bedfordshire NHS Hospital, south wing, Kempston Rd, Bedford, UK. 4 Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan. *Corresponding author’s E-mail: shahnaz.usman@rakmhsu.ac.ae Received: 01-04-2022; Revised: 23-06-2022; Accepted: 30-06-2022; Published on: 15-07-2022. ABSTRACT The major goal of this study was to modify and validate a HPLC analytical method to quantify the pregabalin in its solid dosage form. The separation and quantification were done on waters 3.9 x 300 mm column with 10 µm internal diameter. Mobile phase consisted of acetonitrile: phosphate buffer (KH2PO4) in the ratio of 50:950. Flow rate was 1.5 ml/min whereas the detection was done at 210 nm. The retention time for pregabalin was 6.5 min with average USP tangent of 5730.195± 0.376. There was a good correlation between concentration of pregabalin and their dilutions with r 2 =0.9993. The capacity of method for percent recoveries at three levels over a range of 70-130% were 97.68 - 102.48% with % CV value of 0.73 - 1.95 %. The % CV of intra and inter-day variation was between 0.46 -0.79 and 1.37-0.072 for the concentration of 50, 100 and 150 µg/ml respectively. The results indicated the repeatability, reproducibility and robustness of the method with limit of detection 0.25 µg/ml and 1.0 µg/ml as limit of quantification. The stability study of 160 µg/ml of pregabalin solution (mobile phase) was done to assess the possible decomposition. It was concluded that the proposed method is suitable for routine analysis of pregabalin in its dosage forms. It could be beneficial for the estimation of stability of pregabalin in in-vitro pharmacokinetic studies. Keywords: Optimization and validation of analytical method, ICH parameters for validation, Pregabalin, stability study. QUICK RESPONSE CODE → DOI: 10.47583/ijpsrr.2022.v75i01.023 DOI link: http://dx.doi.org/10.47583/ijpsrr.2022.v75i01.023 INTRODUCTION he analytical method development is a process of demonstrating that the method developed is proper for its intended use. An accurate and reproducible analytical method proves that the obtained data is true and validated. In this regard, HPLC plays an important role in the separation and quantitative identification of components as raw in single or in a mixture. Amount of drug and their metabolites in the unit of pharmaceutical dosage forms are the main and crucial quality characteristics that help to check and confirm the quality, safety, and efficacy of drug substances and drug products. Pregabalin is a structural analogue to gamma- aminobutyric acid (GABA), just as with gabapentin (GBP) 1 . Initially it was used for the treatment of epilepsy, but latter studies described their usefulness in the treatment of neuropathic pain (NeP) 2-4 . It is chemically described as 5- methyl-hexanoic acid. It is white to off-white crystalline solid, freely soluble in water and in basic and acidic aqueous solution 5 . Due to highly soluble and highly permeable compound; the oral absorption is almost 90% and is not dependent of dose and rate of administration. On the other hand, Pregabalin is classified as a schedule V drug in the U.S under Administrative Controlled Substances Code Number (ACSCN) 6 # 2782. It has narrow therapeutic Index and is highly potent drug. It may cause serious side effects/adverse effects if the percentage content of drug per unit is not as per label claim. The main efforts of the current study were to modify and validate HPLC analytical method for the determination of pregabalin in their dosage forms, depending on the availability and feasibility of the facilities. Pregabalin is errant in nature, so the reliable scrutiny of active component in its dosage forms is essential to control the content uniformity and to establish the quality and safety of products. To achieve this goal, HPLC is the most used technique. The basic concept of this method was adapted from Indian Pharmacopoeia 7 2014. MATERIALS AND METHODS Materials Pregabalin was obtained as gift sample from Dr Reddy Laboratories, Hyderabad, India. Potassium hydroxide, hydrochloric acid (Merck), Potassium dihydrogen phosphate (Merck), Sodium Hydroxide (Sigma Aldrich), and distill water was freshly prepared by distillation Modification and Validation of HPLC Analytical Method for the Estimation of Pregabalin in Capsule Dosage Form T Research Article