{"references": ["National Center for Biotechnology Information. PubChem Compound Database; CID=5486971, https://pubchem.ncbi.nlm.nih.gov/compound/5486971.", "Dworkin, Robert H., and Peter Kirkpatrick. \"Pregabalin.\" (2005): 455.", "Hussain Sayyed, Amit Gosar, and Tabrez Shaikh. \"Impurity profiling in Pharmaceuticals: A review\". (2018).", "Robinson, Derek I. \"Control of genotoxic impurities in active pharmaceutical ingredients: a review and perspective.\" Organic Process Research & Development 14.4 (2010): 946-959.", "Blum, M., Grant, D. M., McBride, W., Heim, M., & Meyer, U. A. (1990). Human arylamine N-acetyltransferase genes: isolation, chromosomal localization, and functional expression. DNA and cell biology, 9(3), 193-203.", "Greim, H., Bury, D., Klimisch, H. J., Oeben-Negele, M., & Ziegler-Skylakakis, K. (1998). Toxicity of aliphatic amines: structure-activity relationship. Chemosphere, 36(2), 271-295.", "Swartz, Michael E., and Ira S. Krull. Handbook of analytical validation. CRC Press, 2012.", "Chan, Chung Chow, et al., eds. Analytical method validation and instrument performance verification. John Wiley & Sons, 2004.", "Ermer, Joachim, and John H. McB Miller, eds. John Wiley & Sons, 2006.", "Guideline, ICH Harmonised Tripartite. Q2 (R1).\" International Conference on Harmonization, Geneva, Switzerland. 2005."]}

A highly sensitive high performance liquid chromatography (HPLC) method is developed and validated for the selective trace level determination of (R)-(+)-1-Phenylethylamine impurity, a potential genotoxic that may present in Pregabalin drug substances. HPLC column used was Prontosil 120-5-C18-ace-EPS (250 x 4.6 mm, 5µm). The gradient elution mode was selected where mobile phase-A consist of Buffer (40Mm Diammonium hydrogen o-phosphate solution adjusted to pH 6.5 with dilute orthophosphoric acid) and Methanol and Acetonitrile in ratio 8:1:1 while mobile phase-B as Acetonitrile, The flow rate was set to 0.8 mL/min and run time of 60 minutes. Selected wavelength 210 nm for the analysis on UV detector. The column oven temperature was kept at 25°C. The developed method was validated according to ICH guideline and found to be linear in the range of 1.31 ppm to 3.93 ppm with a correlation coefficient 0.9942. Limit of detection and limit of quantitation was found to be 0.29 ppm and 0.88 ppm respectively. Recovery for this impurity was found between 95.75% and 105.49%. Validation results prove that the method is specific, selective, precise and robust. The developed method can successfully be applied for the determination of genotoxic toxic impurity (R)-(+)-1-Phenylethylamine in Pregabalin.