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

[ Vol. 15 , Issue. 2 ]

Author(s):

Wael Abu Dayyih*, Mohammed Hamad, Eyad Mallah, Alice Abu Dayyih, Kenza Mansour, Zainab Zakarya, Riad Awad and Tawfiq Arafat   Pages 165 - 171 ( 7 )

Abstract:


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 γ-amino-n-butyric acid derivative used as an antiepileptic drug, for the management of fibromyalgia, 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.

Keywords:

Pregabalin, method validation, GC-MS, pharmaceutical preparation.

Affiliation:

Department of Pharmaceutical Medicinal Chemistry and Pharmacognosy, Faculty of Pharmacy and Medical Sciences, University of Petra, Queen Alia International Road P.O. Box: 961343, Amman - Jordan code: 11196, Department of Basic Sciences, Collage of Sciences and Health Professions, King Saud Bin Abdulaziz University for Health Sciences, P.O. Box 9515, Jeddah 21423, Department of Pharmaceutical Medicinal Chemistry and Pharmacognosy, Faculty of Pharmacy and Medical Sciences, University of Petra, Queen Alia International Road P.O. Box: 961343, Amman - Jordan code: 11196, School of Chemistry, Biology and Pharmacy, Hochschule Fresenius University of Applied Science, Limburger StraBe 2, 65510 Idstein, Department of Pharmaceutical Medicinal Chemistry and Pharmacognosy, Faculty of Pharmacy and Medical Sciences, University of Petra, Queen Alia International Road P.O. Box: 961343, Amman - Jordan code: 11196, Department of Pharmaceutical Medicinal Chemistry and Pharmacognosy, Faculty of Pharmacy and Medical Sciences, University of Petra, Queen Alia International Road P.O. Box: 961343, Amman - Jordan code: 11196, Department of Pharmaceutical Medicinal Chemistry and Pharmacognosy, Faculty of Pharmacy and Medical Sciences, University of Petra, Queen Alia International Road P.O. Box: 961343, Amman - Jordan code: 11196, Department of Pharmaceutical Medicinal Chemistry and Pharmacognosy, Faculty of Pharmacy and Medical Sciences, University of Petra, Queen Alia International Road P.O. Box: 961343, Amman - Jordan code: 11196



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