Enhanced HPLC-MS/MS method for the quantitative determination of the co-administered drugs ceftriaxone sodium and lidocaine hydrochloride in human plasma following an intramuscular injection and application to a pharmacokinetic study.

Autor: Mohamed D; Analytical Chemistry Department, Faculty of Pharmacy, Helwan University, Cairo, Egypt.; Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, October University for Modern Sciences and Arts, 6 October City, Egypt., Kamal M; Analytical Chemistry Department, Faculty of Pharmacy, Al-Ahram Canadian University, 6 October City, Egypt.
Jazyk: angličtina
Zdroj: Biomedical chromatography : BMC [Biomed Chromatogr] 2018 Oct; Vol. 32 (10), pp. e4322. Date of Electronic Publication: 2018 Jul 16.
DOI: 10.1002/bmc.4322
Abstrakt: A 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 C 18 (50.0 × 4.6 mm, 5 μm 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 μg/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: C max 141.15 ± 39.84 (μg/mL) and 55.02 ± 9.36 (ng/mL); t max (h) 2.50 ± 0.50 and 1.5 ± 0.50; t ½ (h) 7.30 ± 2.98 and 4.23 ± 1.96; and K el (h -1 ) 0.10 ± 0.04 and 0.20 ± 0.13 for CFT and LDC, respectively.
(© 2018 John Wiley & Sons, Ltd.)
Databáze: MEDLINE
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