Quantitative Determination of Bisoprolol Fumarate by HPLC. I. Method validation

Mahu, Stefania Corina; Spac, Adrian Florin; Ciobanu, Constantin; Hancianu, Monica; Agoroaei, Luminita; Butnaru, Elena

Stefania Corina Mahu, Adrian Florin Spac, Constantin Ciobanu, Monica Hancianu, Luminita Agoroaei, Elena Butnaru

Quantitative Determination of Bisoprolol Fumarate by HPLC. I. Method validation

Abstract:

Bisoprolol belongs to the selective beta-blockers class, initially used for the treatment of cardiac arrhythmias and later in patients with arterial hypertension. A simple and accurate method of high performance liquid chromatography (HPLC) was developed and validated for the determination of bisoprolol fumarate in tablets. The chromatographic analysis was performed using an Eclipse XDB C18 type column (150 mm x 4.6 mm, 5 m) with a mobile phase consisting of a mixture of water / methanol / acetonitrile in a ratio of 50:30:20 (v/v/v). The mobile phase flow rate was 1 mL/min, UV detection being carried out at a wavelength of 225 nm. The injected volume was 20 mL. The temperature of the column compartment was kept constant at 250 C. The HPLC method for the determination of bisoprolol shows two areas of linearity in the range of 0.8 - 80 g/mL and 80 - 1000 g/mL, respectively. Limit of detection for bisoprolol fumarate was 1.3 g/mL and limit of quantification was 3.98 g/mL.The developed method was appropriately validated for linearity, limit of detection, limit of quantification, precision and accuracy in accordance with the international guidelines. The proposed method proved to be simple, precise, and accurate, and can be successfully applied for the determination of bisoprolol in tablets.

Keywords:
bisoprolol fumarate; HPLC; multidiode detector; validation

Issue: 2016, Volume 67, Issue 3

Pages:

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