Abstract
Objective: A rapid, simple and sensitive RP-HPLC method was developed and validated for the determination of bisoprolol fumarate in bulk and pharmaceutical dosage form.Methods: Chromatographic separation was achieved within 2.5 min on ACQUITY Arc System, Waters Symmetry C18 column (3.9 mm i.d. X 150 mm, 5 μm particle sizes) using a mobile phase consisted of acetonitrile: phosphate buffer (25:75 v/v) in an isocratic mode at a flow rate of 1.4 ml/min. The pH of the mobile phase was adjusted to 7.0 with orthophosphoric acid and UV detection was set at 226 nm.Results: The retention time for bisoprolol fumarate was found to be 2.09 min. The proposed method was validated according to ICH guidelines with respect to linearity, specificity precision, accuracy and robustness. The limit of detection and limit of quantification are calculated and found to be 0.4825 and 1.4621 μg/ml; respectively.Conclusion: The proposed method can help research studies, quality control and routine analysis with lesser resources available. The results of the assay of pharmaceutical formulation of the developed method are highly reliable and reproducible and is in good agreement with the label claim of the medicines.Keywords: Bisoprolol, High-Performance Liquid Chromatography, Validation, ICH guidelines
Highlights
Nowadays in the pharmaceutical analysis is dominated by physicochemical methods of analysis, the most reliable of which are methods of chromatographic analysis
Bisoprolol fumarate was obtained as a gift from Farmak pharmaceuticals (Kiev, Ukraine)
HPLC grade acetonitrile, triethylamine, ammonium phosphate, orthophosphoric acid were obtained from Merck pharamaceticals
Summary
Nowadays in the pharmaceutical analysis is dominated by physicochemical methods of analysis, the most reliable of which are methods of chromatographic analysis. Chromatographic methods allow to carry out qualitative and quantitative determination of AFI. Bisoprolol is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent without significant membrane stabilizing activity or intrinsic sympathomimetic activity in its therapeutic dosage range. The chemical name of bisoprolol fumarate is 1-(propan-2ylamino)-3-[4-(2-propan-2-yloxyethoxymethyl) phenoxy] propan-2-ol The two substituents present in the para position of the benzene ring might be the reason for its β1-adrenergic receptor selectivity. The most prominent effect of bisoprolol fumarate is the negative chronotropic effect, resulting in a reduction in resting and exercise heart rate. There is a fall in resting and exercise cardiac output with little observed change in stroke volume, and only a small increase in right atrial pressure, or pulmonary capillary wedge pressure at rest or during exercise [1]
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