Determination of cefdinir in human plasma using HPLC coupled with tandem mass spectroscopy

Application to bioequivalence studies

Lara F. Tutunji, Mohammad Al Bayyari, Sireen Shilbayeh, Maha F. Tutunji

Research output: Contribution to journalArticleResearchpeer-review

1 Citation (Scopus)

Abstract

A sensitive and selective liquid chromatographic method coupled with tandem mass spectrometry has been developed and validated for the determination of cefdinir in human plasma. The analytes cefdinir and cephalexin (internal standard) were separated on a reversed phase column (Merck, Purospher RP-C18, 30 X 4.6 (mm), 3μm) using a mobile phase consisting of an aqueous solution of formic acid in water (0.10%) and acetonitrile (85: 15 v/v (%)), flow rate 0.50 (mL/min.). Detection utilized a tandem MS/MS, the analytes were ionized using an ESI source in the positive ion mode prior to detection and analysis using Multiple Reaction Monitoring mode (MRM). The analytes were monitored at the following transitions (m/z) 396.10 → 226.90, and (m/z) 348.24 → 158.10 for cefdinir and cephalexin respectively. Cefdinir linearity was demonstrated over the concentrations ranging from 10 to 1200 (ng/ mL). The developed method was fully validated prior to its application on a bioequivalence study involving cefdinir (125 mg/5 ml) suspension in healthy volunteers (N= 26) under fasting conditions.

Original languageEnglish
Pages (from-to)123-139
Number of pages17
JournalJordan Journal of Pharmaceutical Sciences
Volume8
Issue number2
Publication statusPublished - 1 Jan 2015

Fingerprint

cefdinir
Therapeutic Equivalency
Mass Spectrometry
High Pressure Liquid Chromatography
Cephalexin
formic acid
Tandem Mass Spectrometry
Fasting
Suspensions
Healthy Volunteers
Ions
Water

Keywords

  • Cefdinir
  • ESI source
  • HPLC-MS/MS
  • MRM mode
  • Plasma
  • Positive ion mode

Cite this

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title = "Determination of cefdinir in human plasma using HPLC coupled with tandem mass spectroscopy: Application to bioequivalence studies",
abstract = "A sensitive and selective liquid chromatographic method coupled with tandem mass spectrometry has been developed and validated for the determination of cefdinir in human plasma. The analytes cefdinir and cephalexin (internal standard) were separated on a reversed phase column (Merck, Purospher RP-C18, 30 X 4.6 (mm), 3μm) using a mobile phase consisting of an aqueous solution of formic acid in water (0.10{\%}) and acetonitrile (85: 15 v/v ({\%})), flow rate 0.50 (mL/min.). Detection utilized a tandem MS/MS, the analytes were ionized using an ESI source in the positive ion mode prior to detection and analysis using Multiple Reaction Monitoring mode (MRM). The analytes were monitored at the following transitions (m/z) 396.10 → 226.90, and (m/z) 348.24 → 158.10 for cefdinir and cephalexin respectively. Cefdinir linearity was demonstrated over the concentrations ranging from 10 to 1200 (ng/ mL). The developed method was fully validated prior to its application on a bioequivalence study involving cefdinir (125 mg/5 ml) suspension in healthy volunteers (N= 26) under fasting conditions.",
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Determination of cefdinir in human plasma using HPLC coupled with tandem mass spectroscopy : Application to bioequivalence studies. / Tutunji, Lara F.; Al Bayyari, Mohammad; Shilbayeh, Sireen; Tutunji, Maha F.

In: Jordan Journal of Pharmaceutical Sciences, Vol. 8, No. 2, 01.01.2015, p. 123-139.

Research output: Contribution to journalArticleResearchpeer-review

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T1 - Determination of cefdinir in human plasma using HPLC coupled with tandem mass spectroscopy

T2 - Application to bioequivalence studies

AU - Tutunji, Lara F.

AU - Al Bayyari, Mohammad

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AU - Tutunji, Maha F.

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