title: LC-MS/MS Determination of Empagliflozin and Metformin.
abstract: A new LC-MS/MS method was developed for determination of empagliflozin and metformin. Bridged Ethylene Hybrid C18 column (50 mm × 2.1 mm, 1.7 μm), isocratic elution based on 0.1% aqueous formic acid:acetonitrile (75:25, v/v) as a mobile phase, column temperature at 55°C and flow rate at 0.2 mL min-1 were used. The mass spectrometer was operated under multiple reaction monitoring mode using electrospray ionization by monitoring the transition pairs (precursor to product ion) of m/z 451.04-71.07 for empagliflozin and m/z 130.11-71.14 for metformin in the positive mode. The validation parameters were acceptable over concentration ranges of 5-1,000 ng mL-1 and 50-25,000 ng mL-1 for empagliflozin and metformin, respectively. The optimized method was validated according to International Conference on Harmonization guidelines. Regression parameters, limit of detection, limit of quantification, accuracy, precision and pharmaceutical formulation analysis were investigated. The developed method was proved to be accurate for the quality control of recently approved Synjardy® tablets.
authors.affiliation: Pharmaceutical Chemistry Department, Faculty of Pharmacy, The British University in Egypt (BUE), El-Sherouk city, Cairo 11837, Egypt.|The Center for Drug Research and Development (CDRD), Faculty of Pharmacy, The British University in Egypt (BUE), El-Sherouk city, Cairo 11837, Egypt.
authors.forename: Bassam M
authors.initials: BM
authors.lastname: Ayoub
authors.affiliation: Pharmaceutical Chemistry Department, Faculty of Pharmacy, The British University in Egypt (BUE), El-Sherouk city, Cairo 11837, Egypt.|The Center for Drug Research and Development (CDRD), Faculty of Pharmacy, The British University in Egypt (BUE), El-Sherouk city, Cairo 11837, Egypt.|Analytical Chemistry Department, Faculty of Pharmacy, Helwan University, Ein Helwan, Cairo 11795, Egypt.
authors.forename: Shereen
authors.initials: S
authors.lastname: Mowaka
mesh_terms: D001559:Benzhydryl Compounds / Q000032:analysis* / Q000737:chemistry; D002853:Chromatography, Liquid / Q000379:methods*; D005960:Glucosides / Q000032:analysis* / Q000737:chemistry; D057230:Limit of Detection; D016014:Linear Models; D008687:Metformin / Q000032:analysis* / Q000737:chemistry; D015203:Reproducibility of Results; D013607:Tablets; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D001559:Benzhydryl Compounds; D005960:Glucosides; D013607:Tablets; D008687:Metformin; C570240:empagliflozin