Development and Validation of a UPLC-DAD Method for the Simultaneous Quantification of Eight Antihypertensive Drugs in the Pharmaceutical Matrix

Abstract

Background: Hypertension is a critical health problem; it is a prevalent risk factor for cardiovascular disease. Many treatments to combat hypertension are available, however many patients are resistant to the standard therapeutic approaches. The association of two or more substances in a fixed-dose combination is effective and tolerated as a substitute for the standard therapeutic approach.

Objective: The new ultra performance liquide chromatography method was developed and validated to assay a combination of eight antihypertensive drugs including a diuretic: hydrochlorothiazide, dihydropyridine calcium channel blocker: Amlodipine and angiotensin II type 1 receptor blockers (sartans): valsartan, candesartan, eprosartan, olmesartan, losartan, and irbesartan in the pharmaceutical matrix.

Methods: Chromatographic separation was performed on an Acquity® UPLC C18 1.7 µm 2.1 × 100 mm column, with a gradient of buffer solution and acetonitrile, in the proportion of (80:20 v/v).

Results: Good resolution was obtained, and an optimal analysis time of less than 5 min was achieved. The method was validated according to the International Conference on Harmonization guidelines following the classical approach and accuracy profile, and it is shown to be suitable for intended applications. The method was successfully used for quality control laboratories and the determination of these drugs combinations in pharmaceutical dosage forms.