Cardiovascular drugs are the main components of many formulations in marketplace. Herein, a fast high-performance liquid chromatographic assay was developed for the determination of pharmaceutical preparations containing antihypertensive agents including Atenolol (ATE), Hydrochlorothiazide (HCT), Ramipril (RAM), Amlodipine (AML), Losartan (LOS) and Telmisartan (TEL). Optimum separation was achieved using RP-C8 Waters Symmetry column (3.5 μm, 4.6 mm × 150 mm) and a mobile phase composed of 25 mM potassium phosphate buffer (pH 4.5 ± 0.1) and acetonitrile in gradient elution mode at 1.0 mL/min flow rate and 230 nm detection wavelength. Analysis was achieved in less than 9 min. The method was fully validated according to ICH guidelines. Linearity was achieved over the range of 10.0 – 60.0 μg/mL for ATE, LOS, Tel, 5.0 – 50.0 μg/mL for HCT, AML, and 1.0 – 11.0 μg/mL for RAM with acceptable accuracy, precision and limits of detection (< 2.0 μg/mL). Method robustness was assessed using small changes in buffer pH, acetonitrile ratio of the mobile phase, flow rate and detection wavelength. The proposed method was successfully applied to the analysis of their dosage forms combinations. Statistical comparison between the proposed and official methods was performed. The optimized method offers an economic chromatographic tool for the routine analysis of cardiovascular drugs in pharmaceutical quality control laboratories.
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Saeed, S., Nadim, A.H., Yehia, A.M. et al. A Generic High-Performance Liquid Chromatographic Method for Simultaneous Determination of Six Cardiovascular Drugs: Method Optimization and Application to Various Pharmaceutical Formulations. Pharm Chem J 57, 138–145 (2023). https://doi.org/10.1007/s11094-023-02861-w
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DOI: https://doi.org/10.1007/s11094-023-02861-w