Key result
A sensitive and selective LC-MS method was successfully developed, validated, and applied to determine the pharmacokinetic profiles of 16 mg candesartan and 12.5 mg hydrochlorothiazide in 36 healthy male volunteers.
A validated LC-MS method allows for sensitive and simultaneous quantification of candesartan and hydrochlorothiazide in human plasma for pharmacokinetic monitoring.
Provides validated LC-MS tool for simultaneous candesartan/HCTZ PK monitoring; leaves open clinical application beyond healthy volunteers.
Quantitative determination of hydrochlorothiazide (HCTZ) and candesartan (CDS) in human plasma in volunteers was performed using a sensitive, selective and specific LC-MS method which has been developed and validated before the study. The study was performed by means of a liquid chromatograph Shimadzu Prominence equipped with a mass spectrometer LCMS-2020. Analytical column PerfectBond ODS-HD HPLC-column 5 μm 250 × 3.0 mm with a pre-column cartridge PerfectBond ODS-HD 5 μm 10 × 3.0 mm, double source of ionization for LCMS-2020 (electrospray (ESI) and chemical (APCI)) and software LabSol LCMS V5 LCMS2020 systempack were used. The low limit of the quantitative determination for HCTZ and CDS made up 10 ng/ml. m/z for CDS 441.20—positive scan, m/z for HCTZ 295.90—negative scan. The method has been applied to a pharmacokinetic study of 12.5 mg HCTZ and 16 mg CDS tablet in healthy volunteers.
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Brushinina et al. (2014) studied Healthy (n=36). Candesartan and Hydrochlorothiazide was evaluated on Pharmacokinetic parameters (Cmax, Tmax, AUC). A sensitive and selective LC-MS method was successfully developed, validated, and applied to determine the pharmacokinetic profiles of 16 mg candesartan and 12.5 mg hydrochlorothiazide in 36 healthy male volunteers.
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