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.