Development And Validation of Stability Indicating RP-HPLC Method For Quantification of Bisoprolol Fumarate and Telmisartan in Tablet Dosage Form

Background: An anti-hypertensive drug having combination of Bisoprolol Fumarate and Telmisartan is used for the treatment of hypertension. Objective: This study aimed to develop, validate, and apply stability-indicating RP-HPLC method for quantitative estimation of Bisoprolol Fumarate and Telmisartan from Tablet dosage form. Method: Bisoprolol Fumarate and Telmisartan were separated by developing the Stability indicating RP-HPLC method on Hibar ODS C18 column (250 mm × 4.6 mm, 5 µm) in an isocratic mode using a mobile phase of Acetonitrile: 10 mM Phosphate Buffer (70: 30 v/v) with a flowrate of 1.0 ml/min and UV detection was carried out at 230 nm. Both drugs were subjected to stress conditions like acidic, basic, oxidative, and thermal degradation. Results: The proposed method is capable to separate and quantify the components from their combination. The proposed was able to detect the degradants of both drugs. The method was validated according to the guidelines described in the International Council for Harmonization guideline. Conclusion: The RP-HPLC method for assay of market formulations of Bisoprolol Fumarate and Telmisartan was successfully developed, validated, and found to be simple, accurate, precise, reproducible, sensitive, and robust and stability-indicating. Highlights: These findings suggested that the proposed RP-HPLC method can be employed in routine assay of Bisoprolol Fumarate and Telmisartan in combined formulation