US FDA-Validated Green GC–MS Method for Analysis of Gabapentin, Tramadol and/or Amitriptyline Mixtures in Biological Fluids

Abstract

Background: Mixtures of gabapentin, tramadol and/or amitriptyline are usually recommended for treatment of neuropathic pain. Materials & methods/results: A novel GC–MS/MS method was developed to assess the studied mixture whether in pure forms or human biological fluids (plasma/urine). The chromatographic detection was performed using MS detector applying the selected ion-monitoring mode. An (Agilent, CA, USA) GC–MS with triple axis single quadrupole detector unit was used for the analysis equipped with HP-5MS (5% phenyl methyl siloxane) column. Helium was the carrier gas and positive electron impact ionization mode was applied. Conclusion: The developed method was able to assess the mixture components simultaneously within six minutes. Validation of the method was assured according to US FDA guidelines and Eco-Scale assessment.

Development and validation of an improved QuEChERS method for the extraction of semi-volatile organic compounds (SVOCs) from complex soils

“…In accordance with the manual for the determination of phthalate metabolites by the Centers for Disease Control and Prevention (CDC), 33 as well as the research conducted by Dekic, Szyposzynska, and Naguib, among others, the employment of the HP-5ms chromatographic column demonstrates an exceptional prowess in the analysis of tetrabromobisphenol A and a series of non-chiral menthol esters, alongside the amalgamation of gabapentin, tramadol, and/or amitriptyline within biological fluids. 34–36 This chromatographic column has extremely low bleed characteristics and is crosslinked for solvent rinsing, making it an ideal chromatographic column for GC/MS analysis. It is equivalent to the US Pharmacopeia (USP) gas chromatography column stationary phase G27, which can improve signal-to-noise ratio, resulting in higher sensitivity and more complete mass spectral information.…”

First derivative synchronous spectrofluorimetric method for the simultaneous determination of tramadol and celecoxib in their dosage forms and human plasma

“…1), an analgesic medication with dual monoaminergic reuptake inhibitory and opioid receptor agonist activities, is used for neuropathic pain, osteoarthritic pain as well as low back and rheumatoid arthritis [22]. Reported analytical methods for tramadol alone or in combinations include HPLC [23][24][25][26][27][28], spectrophotometric methods [29][30][31], electrochemical methods [32][33][34][35] and gas Chromatography [36,37].…”

Development and validation of a new spectrophotometric method for the determination of gabapentin in capsules

“…Chromatographic methods of analysis are widely used to determine gabapentin in biological fluids and dosage forms. The determination of gabapentin by the methods of high-performance liquid chromatography (HPLC) [3][4][5], high-performance thin-layer chromatography (HPTLC) [6], thin-layer (LC-MS/MS) [7], gas chromatography (GC-MS) [8], and also by methods of capillary electrophoresis [9], voltammetry, potentiometry, etc.…”