A simple, reproducible and fast (4 min chromatogram) method of liquid chromatography in tandem with mass spectrometry (LC/MS-MS) was developed to determine simultaneously the plasma levels of albendazole (ABZ) and its metabolite albendazole sulfoxide (ABZOX) for pharmacokinetic and clinical analysis. Each plasma sample was extracted by solid phase extraction (SPE) using phenacetin as internal standard (IS). The extracted sample was eluted with a Zorbax XDB-CN column using an isocratic method. The mobile phase consisting of water with 1% acetic acid (40%, A) and MeOH (60%, B), was used at a flow rate of 1 mL/min. ABZ and ABZOX were detected and identified by mass spectrometry with electrospray ionization (ESI) in the positive ion and multiple-reaction monitoring (MRM) mode. The method was linear in the range of 5-1000 ng/mL for ABZ and 10-1500 ng/mL (full validation) or 10-5000 ng/mL (partial validation) for ABZOX, with 5 and 10 ng/mL lower limit of quantification (LLOQ) for ABZ and ABZOX, respectively. The tests of accuracy and precision, matrix effect, extraction recovery and stability of the samples for both ABZ and ABZOX did not deviate more than 20% for the LLOQ and no more than 15% for other quality controls (QCs), according to regulatory agencies.
Keywords: ABZ; ABZOX; Albendazole; Albendazole sulfoxide; C(max); CV; EDTA; EIC; EMA; ESI; European Medicine Agency; FDA; HPLC; IS; LC/MS–MS; LLOQ; Liquid chromatography in tandem with mass spectrometry; MRM; MeOH; Parasitic infections; QC; RT; SD; SPE; Solid phase extraction; TIC; UV; albendazole; albendazole sulfoxide; coefficient of variation; electrospray ionization; ethylenediaminetetraacetic acid; extraction ion chromatogram; high performance liquid chromatography; internal standard; liquid chromatography in tandem with mass spectrometry; lower limit of quantification; maximal plasma concentration; methanol; multiple-reaction monitoring; quality control; regulatory agency Food and Drug Administration; retention time; solid phase extraction; standard deviation; total ion chromatogram; ultra-violet.
© 2013.