Development And Validation Of Uplc Methods For Simultaneous Determination Of Selected Antihypertensive Drugs In Their Dosage Forms
Accurate, precise and sensitive UPLC methods were developed and validated for the simultaneous
determination of selected antihypertensive drugs; a binary mixture containing Lercanidipine HCl (LER) and Enalapril
maleate (ENA), and a ternary mixture containing amlodipine besylate (AML), olmesartan medoxomil (OLM) and
hydrochlorothiazide (HCT). Chromatographic separation was achieved using Kinetex™ column – C18 (4.6 x 150 mm, 2.6
μm). Isocratic elution at a flow rate 1 mL/min was performed using a mobile phase of methanol: phosphate buffer pH = 3.0
± 0.1 (65: 35 v/v), for the binary mixture and acetonitrile: phosphate buffer pH = 3.0 ± 0.1 (45: 55 v/v), for the ternary
mixture. The methods developed were satisfactorily applied to the analysis of the pharmaceutical formulations and proved
to be specific and accurate for the quality control of the cited drugs in pharmaceutical dosage forms. The obtained results are
statistically compared with those obtained by the official or reported methods, showing no significant difference with respect
to accuracy and precision at p=0.05.
Index Terms—antihypertensive, binary mixture, ternary mixture, UPLC.