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Open AccessArticle

Enhanced Extraction Technique of Omarigliptin from Human Plasma—Applied to Biological Samples from Healthy Human Volunteers

1
Pharmaceutical Chemistry Department, Faculty of Pharmacy, The British University in Egypt, El-Sherouk City, Cairo 11837, Egypt
2
The Center for Drug Research and Development (CDRD), Faculty of Pharmacy, The British University in Egypt, El-Sherouk City, Cairo 11837, Egypt
3
Analytical Chemistry Department, Faculty of Pharmacy, Helwan University, Ain Helwan, Cairo 11795, Egypt
4
Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, The British University in Egypt, El-Sherouk City, Cairo 11837, Egypt
5
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Organization of African Unity Street, Abassia, Cairo 11566, Egypt
*
Author to whom correspondence should be addressed.
Academic Editor: Roberto Mandrioli
Molecules 2020, 25(18), 4232; https://doi.org/10.3390/molecules25184232
Received: 13 August 2020 / Revised: 8 September 2020 / Accepted: 12 September 2020 / Published: 15 September 2020
(This article belongs to the Special Issue Bioanalysis and Biological Matrix Sampling)
Enhancing drug extraction from human plasma is a challenging approach that critically affects pharmacokinetic and any further clinical studies based on the drug Cmin and Cmax values. It also has a serious impact on the sensitivity and the lower limit of quantification (LLOQ) value of the bio-analytical methods. An advanced liquid chromatography tandem mass spectrometry (LC-MS/MS) bio-analytical method of omarigliptin (25–1000 nM) was established in human plasma using one-step liquid-liquid extraction. Alogliptin was used as an internal standard (IS) to attain good recovery and reproducibility while reducing the effects of the matrix. Enhanced plasma extraction of omarigliptin was successfully achieved with tertiary butyl methyl ether—diethyl ether (TBME-DEE) mixture as the extracting solvent, while using acetonitrile as the diluent solvent for the IS to effectively decrease the formed emulsion. Multiple Reaction Monitoring (MRM) of the transition pairs of m/z 399.2 to 153.0 for omarigliptin and m/z 340.2 to 116.0 for alogliptin was employed in positive Electro Spray Ionization (ESI) mode. Human plasma samples were collected after 1.5 h (tmax) of Marizev® (12.5 mg) tablets administration to healthy human volunteers showing average concentration of 292.18 nM. Validation results were all satisfactory including successful stability studies with bias below 12%. The proposed study will be valuable for ethnicity comparison studies that will be commenced on omarigliptin in Egypt by the authors in prospective study, following the FDA recommends, to evaluate possible sub-group dissimilarities that include pharmacokinetic parameters. View Full-Text
Keywords: enhanced extraction; human plasma; human volunteers; LC-MS/MS; omarigliptin enhanced extraction; human plasma; human volunteers; LC-MS/MS; omarigliptin
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MDPI and ACS Style

Mowaka, S.; Ashoush, N.; Tadros, M.; El Zahar, N.; Ayoub, B. Enhanced Extraction Technique of Omarigliptin from Human Plasma—Applied to Biological Samples from Healthy Human Volunteers. Molecules 2020, 25, 4232. https://doi.org/10.3390/molecules25184232

AMA Style

Mowaka S, Ashoush N, Tadros M, El Zahar N, Ayoub B. Enhanced Extraction Technique of Omarigliptin from Human Plasma—Applied to Biological Samples from Healthy Human Volunteers. Molecules. 2020; 25(18):4232. https://doi.org/10.3390/molecules25184232

Chicago/Turabian Style

Mowaka, Shereen; Ashoush, Nermeen; Tadros, Mariam; El Zahar, Noha; Ayoub, Bassam. 2020. "Enhanced Extraction Technique of Omarigliptin from Human Plasma—Applied to Biological Samples from Healthy Human Volunteers" Molecules 25, no. 18: 4232. https://doi.org/10.3390/molecules25184232

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