Novel Stability Indicating UPLC Method Development and Validation for Simultaneous Quantification of Perindopril Arginine and Bisoprolol Fumarate in Pure and Pharmaceutical Dosage Form

A novel stability-indicating UPLC method was developed and validated for the simultaneous quantification of perindopril arginine (PeA) and bisoprolol fumarate (BiF) in both pure and pharmaceutical dosage forms. The method utilized a Waters ACQUITY UPLC system with a BEH C۱۸ column (۲.۱ mm × ۱۰۰ mm, ۱.۷ µm), employing an isocratic mobile phase of Acetonitrile and ۰.۱% Trifluoroacetic Acid (۴۰:۶۰, v/v) at a flow rate of ۰.۲ mL/min and a detection wavelength of ۲۴۷ nm. The method was validated according to the ICH guidelines for linearity, precision, accuracy, robustness, and forced degradation studies. It exhibited excellent linearity (R² = ۰.۹۹۹۸۹ for PeA and R² = ۰.۹۹۹۵۷ for BiF) over the respective concentration ranges. System suitability parameters confirmed the robustness, with plate counts exceeding ۷,۵۰۰ and tailing factors less than ۱.۰۵. The method demonstrated high precision with %RSD values less than ۱.۵% and remained robust under minor variations in flow rate and mobile phase composition. Forced degradation studies showed significant degradation under peroxide (۱۳.۵% and ۱۲.۵%), acid (۱۲.۶% and ۱۰.۹%), and alkali conditions (۱۰.۴% and ۱۱.۲%) for PeA and BiF, respectively, confirming the stability-indicating capability of the method. This UPLC method is rapid, precise, and suitable for routine quality control in pharmaceutical formulations, effectively distinguishing degradation products and ensuring regulatory compliance. Future studies could focus on expanding the applicability of this UPLC method to other fixed-dose combinations of antihypertensive drugs to ensure broader regulatory compliance and quality control in pharmaceutical formulations. In addition, further investigations on the degradation kinetics and identification of degradation products using mass spectrometry could enhance the understanding of the stability profiles. The method can also be adapted for therapeutic drug monitoring and bioanalytical applications in plasma, supporting pharmacokinetic and bioequivalence studies.

کلیدواژه ها:

Perindopril arginine ، Bisoprolol fumarate ، UPLC ، Stability-indicating method ، Forced degradation