Determination of Cefdinir in Human Plasma using HPLC Coupled with Tandem Mass Spectroscopy: Application to Bioequivalence Studies

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

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.

Keywords


Cefdinir, HPLC-MS/MS, plasma, ESI source, positive ion mode, MRM mode

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