Determination of fenticonazole in human plasma by HPLC–MS/MS and its application to pharmacokinetic studies

Abstract

Two simple and sensitive high performance liquid chromatography–tandem mass spectrometry (HPLC–MS/MS) methods were developed and validated for the determination of fenticonazole in human plasma after percutaneous and intravaginal administration. Mifepristone was used as an internal standard (IS), and simple protein precipitation by acetonitrile containing 2% acetic acid was utilized for extracting the analytes from the plasma samples. Chromatographic separation was performed on a Kinetex XB-C18 column. The quantitation was performed by a mass spectrometer equipped with an electrospray ionization source in multiple reactions monitoring (MRM) positive ion mode using precursor-to-product ion transitions of m/z 455.2–199.1 for fenticonazole and m/z 430.2–372.3 for mifepristone. The validated linear ranges were 5–1000 pg/mL and 0.1–20 ng/mL fenticonazole in plasma for the methods A and B, respectively. For the two methods, the accuracy data ranged from 85% to 115%, the intra- and inter-batch precision data were less than 15%, the recovery data were more than 90%, and no matrix interference was observed. The methods A and B were successfully validated and applied to the pharmacokinetic studies of fenticonazole gel in Chinese healthy volunteers after percutaneous and intravaginal administration, respectively.

Development of novel HPTLC method for determination of imidazole antifungal drug fenticonazole: Exploring hydrotropy

“…3 This hydrotropy concept is mainly applied to the UV-Spectrophotometry for the determination of different pharmaceuticals. 4,5 A detailed literature revealed few analytical and bioanalytical methods such as UV-Spectrophotometry 6 , RP-HPLC [7][8][9] , capillary electrophoresis 10 and LC-MS 2,11,12 reported for the determination of FTZ.…”

Review—Electrochemical Sensors Used for the Determination of Some Antifungal Azoles

“…The European Pharmacopeia recommends using potentiometric titration for species like fenticonazole, econazole, ketoconazole, isoconazole, bifonazole, fluconazole, and itraconazole, while for voriconazole indicates to use liquid chromatography. 21 A literature survey revealed the use of other methods to determine these compounds, such as high-performance liquid chromatography (HPLC) with UV detection, 22 HPLC with diode array detection (HPLC-DAD), 23 HPLC-tandem mass spectrometry (HPLC-MS/MS), 24,25 liquid chromatography-tandem mass spectrometry (LC-MS/MS), [26][27][28] reversedphase HPLC (RP-HPLC) with UV detection, 29 sequential injection analysis (SIA) with spectrophotometric detection, 30 spectrophotometry, 31,32 and capillary electrophoresis (CE). [33][34][35] Although these techniques are widely used due to their robustness, sensitivity, and reliability, they require large amounts of reagents, expensive equipment, sample pretreatment, and specialized personnel.…”