Determination of Genotoxic Impurity (R)-(+)-1-Phenylethylamine in Pregabalin Drug Substances by High Performance Liquid Chromatography
Authors/Creators
- 1. Associate Professor, Sir Sayyed College of Arts, Commerce and Science, P.G. Department of Chemistry, Aurangabad, Maharashtra, India
- 2. Chief Scientist, Indoco remedies Ltd, Rabale, Navimumbai, Maharashtra, India
- 3. Principal Scientist, Indoco remedies Ltd, Rabale, Navimumbai, Maharashtra, India
- 4. Principal Scientist, Sir Sayyed College of Arts, Commerce and Science, P.G. Department of Chemistry, Aurangabad, Maharashtra, India
- 5. Principal Scientist, Jawahar College, Department of Chemistry, Andur, Dist. Osmanabad, Maharashtra, India
Description
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.
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Additional details
References
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