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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.
Mirodenafil is a 5-phosphodiesterase inhibitor that is currently marketed
in Korea for the treatment of erectile dysfunction; however, no information in
other populations is available. It has been described that Mirodenafil is
metabolized by CYP3A4, a metabolic pathway in which interethnic differences
have been reported. The purpose of this study was to characterize the oral
pharmacokinetics of Mirodenafil in Mexicans. Seventeen male healthy volunteers
were enrolled in this study. After an overnight fast, volunteers received an
oral 100 mg dose and blood samples were collected at selected times during 24
h. Plasma was stored frozen and analyzed by an HPLC method. Pharmacokinetic
parameters obtained were: Cmax 331.129 ± 32.689 ng/mL, tmax 1.574 ± 0.293 h, AUC24h 883.293 ± 104.088 ng·h/mL,
AUC￥ 976.477 ± 108.812 ng·h/mL and t1/2 1.807 ± 0.171 h.
Parameter values observed in this study are similar to those reported in
Koreans. Since efficacy and safety studies of Mirodenafil have been conducted
in Koreans, it is expected that dosage regime to employ in Mexicans should be
similar to the approved for Korean population.