Akademik Veri Yönetim Sistemi
CHROMATOGRAPHIA, cilt.76, sa.21-22, ss.1487-1494, 2013 (SCI-Expanded)
High efficiency and less elution are the basic requirements of high-speed chromatographic separation. In this study, a new gradient reverse phase chromatographic methods were developed using HPLC and UPLC systems for simultaneous determination of enalapril maleate (ENL) and hydrochlorothiazide (HCZ) in pharmaceutical dosage forms. The chromatographic separations of ENL and HCZ were achieved on a Waters mu-Bondapak C 18, (300 x 3.9 mm, 10 mu m) and Waters Acquity BEH C18 (100 x 2.1 mm, 1.7 mu m) columns for HPLC within 5.30 min and UPLC within a short retention time of 1.95 min, respectively. A linear response was observed over the concentration range 0.270-399 mu g mL(-1) of ENL, 0.260-399 mu g mL(-1) of HCZ for HPLC system and 0.270-399 mu g mL(-1) of ENL and 0.065-249 mu g mL(-1) of HCZ for UPLC system. Also, limit of detection for ENL was 1.848 ng mL(-1) and 31.477 ng mL(-1) for HCZ, 2.804 ng mL(-1) for ENL and 2.943 ng mL(-1) for HCZ using HPLC and UPLC, respectively. The proposed methods were validated according to ICH guideline with respect to precision, accuracy, and linearity. Forced degradation studies were also performed for both compounds in bulk drug samples to demonstrate the specificity and stability indicating power of the HPLC method. Comparison of system performance with conventional HPLC was made with respect to analysis time, efficiency, and resolution.