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
Mohamed D.; Kamal M.
Date issued:
2018
Publisher:
John Wiley and Sons Ltd
Series Info:
Biomedical Chromatography
32
Type:
Article
Keywords:
ceftriaxone sodium
,
high performance liquid chromatography coupled to tandem mass spectrometry (HPLC�MS/MS)
,
human plasma
,
lidocaine hydrochloride
,
pharmacokinetics
,
cefixime
,
ceftriaxone
,
lidocaine
,
tadalafil
,
ceftriaxone
,
lidocaine
,
area under the curve
,
Article
,
controlled study
,
drug blood level
,
drug determination
,
drug elimination
,
drug half life
,
Egyptian
,
high performance liquid chromatography
,
human
,
limit of quantitation
,
maximum concentration
,
multiple reaction monitoring
,
normal human
,
plasma concentration-time curve
,
quantitative analysis
,
tandem mass spectrometry
,
time to maximum plasma concentration
,
blood
,
chemistry
,
drug stability
,
high performance liquid chromatography
,
intramuscular drug administration
,
procedures
,
reproducibility
,
sensitivity and specificity
,
statistical model
,
tandem mass spectrometry
,
Ceftriaxone
,
Chromatography, High Pressure Liquid
,
Drug Stability
,
Humans
,
Injections, Intramuscular
,
Lidocaine
,
Linear Models
,
Reproducibility of Results
,
Sensitivity and Specificity
,
Tandem Mass Spectrometry
Abstract:
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 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.
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