article · International Journal of Applied Pharmaceutics
A rapid, simple, and sensitive reversed-phase high-performance liquid chromatography method has been developed and validated to measure bisoprolol fumarate in bulk materials and tablet dosage forms. Separation was completed within 2.5 minutes using a Waters Symmetry C18 column and an isocratic mobile phase composed of acetonitrile and phosphate buffer at a flow rate of 1.4 millilitres per minute with ultraviolet detection set at 226 nanometres. The retention time for the drug was 2.09 minutes. Validation conducted according to International Council for Harmonisation guidelines established the linearity, specificity, precision, accuracy, and robustness of the technique. The limit of detection was calculated as 0.4825 micrograms per millilitre and the limit of quantification was 1.4621 micrograms per millilitre. The resulting assay delivers reliable, reproducible measurements that align with medicine label claims.
Testing active ingredients in medicines ensures that patients receive safe and accurately dosed treatments. Standard pharmaceutical testing protocols can be slow and resource-intensive. This analytical method provides a rapid, reproducible procedure for quantifying bisoprolol fumarate, enabling laboratories to verify product quality and confirm that manufactured tablets match their stated specifications efficiently.
This method is an applied analytical protocol suited for quality control laboratories, pharmaceutical manufacturers, and regulatory testing facilities analysing bisoprolol tablets. Because it has been validated under standard international guidelines and tested on pharmaceutical formulations, the technique is near-market and ready for immediate operational adoption in routine testing, particularly in laboratories operating with fewer analytical resources.
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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
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DOI: 10.22159/ijap.2017v9i6.21616
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