Mohamed D.Kamal M.Analytical Chemistry DepartmentFaculty of PharmacyHelwan UniversityCairoEgypt; Pharmaceutical Analytical Chemistry DepartmentFaculty of PharmacyOctober University for Modern Sciences and Arts6 October CityEgypt; Analytical Chemistry DepartmentFaculty of PharmacyAl-Ahram Canadian University6 October CityEgypt2020-01-092020-01-0920182693879https://doi.org/10.1002/bmc.4322PubMed ID 29934999https://t.ly/R03WDScopusA sensitive HPLC�MS/MS method was established for the quantification of ceftriaxone sodium (CFT) and lidocaine HCl (LDC) in human plasma utilizing cefixime (CFX) and tadalafil (TDA) as internal standards. The analytes were extracted from human plasma by protein precipitation using acetonitrile. Chromatographic separation was performed on Kinetex C18 (50.0 � 4.6 mm, 5 ?m particle size) column with methanol�0.01�M ammonium acetate pH 6.4 (70: 30, v/v) as mobile phase. Multiple reaction monitoring involving the transitions 555.10 ? 396.20, 235.20 ? 86.00, 454.20 ? 284.80 and 390.20 ? 268.20 was utilized to quantify CFT, LDC, CFX and TDA, respectively, using a triple quadrupole mass spectrometer which was operated in positive ion mode. The method revealed linearity in the concentration range of 3.0�300.0 ?g/mL for CFT and 3.0�300.0 ng/mL for LDC. The validation of the method was achieved in accordance to the US Food and Drug Administration guidelines. A pharmacokinetic study was performed on healthy Egyptian volunteers after intramuscular injection of sterile ceftriaxone sodium (1 g CFT dissolved in 3.5 mL of 1% LDC) after approval from the ethics committee. The pharmacokinetic parameters were: Cmax 141.15 � 39.84 (?g/mL) and 55.02 � 9.36 (ng/mL); tmax (h) 2.50 � 0.50 and 1.5 � 0.50; t� (h) 7.30 � 2.98 and 4.23 � 1.96; and Kel (h?1) 0.10 � 0.04 and 0.20 � 0.13 for CFT and LDC, respectively. � 2018 John Wiley & Sons, Ltd.Englishceftriaxone sodiumhigh performance liquid chromatography coupled to tandem mass spectrometry (HPLC�MS/MS)human plasmalidocaine hydrochloridepharmacokineticscefiximeceftriaxonelidocainetadalafilceftriaxonelidocainearea under the curveArticlecontrolled studydrug blood leveldrug determinationdrug eliminationdrug half lifeEgyptianhigh performance liquid chromatographyhumanlimit of quantitationmaximum concentrationmultiple reaction monitoringnormal humanplasma concentration-time curvequantitative analysistandem mass spectrometrytime to maximum plasma concentrationbloodchemistrydrug stabilityhigh performance liquid chromatographyintramuscular drug administrationproceduresreproducibilitysensitivity and specificitystatistical modeltandem mass spectrometryCeftriaxoneChromatography, High Pressure LiquidDrug StabilityHumansInjections, IntramuscularLidocaineLinear ModelsReproducibility of ResultsSensitivity and SpecificityTandem Mass SpectrometryArticlehttps://doi.org/10.1002/bmc.4322PubMed ID 29934999