Establishment and Validation of a Sensitive Method for the Detection of Pregabalin in Pharmacological Formulation by GC/MS Spectrometry

Background: A gas chromatography and mass spectrometry (GC/MS) procedure was developed and validated for the evaluation and quantification of pregabalin (PGN) in pharmaceutical preparations. Introduction: Pregabalin is a γ-amino-n-butyric acid derivative used as an antiepileptic drug for the management of fibromyalgia, and has analgesic, anxiolytic, and anticonvulsant activities. Few studies have been reported on the determination of PGN content in pharmaceutical preparations involving gas chromatography - mass spectroscopy. Methods: Pregabalin was extracted with MSTFA/NH4F/β- mercapto-ethanol at 60°C for 30 min. The acquired derived molecule of pregabalin was identified by specific ion monitoring mode applying the analytical ions m/z 232 and 331. Propranolol was used as Internal Standard (IS). The following validation parameters were taken into consideration: precision, linearity, accuracy, stability, specificity, robustness, ruggedness, Limit Of Detection (LOD) and Limit Of Quantitation (LOQ). Results: The method was selective, precise, sensitive, linear and specific. The linearity of the method was between 3.5 and 300 ng/ml. The precise values were ≤ 3.62% of both intra- and interday validation. The LOD accurate values for Intraday and interday validation were in the range of -0. 25 -2.05%. While LOQ accurate values for intraday and interday were 1.5x10-6 and 3.5 x10-6mg/ml, respectively. Conclusion: Therefore, the developed GC-MS method was effectively implemented to identify PGN in a pharmacological preparation.