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Fast RP-HPLC Method for the Determination of Bisoprolol.

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    A new high-performance liquid chromatography (HPLC) method accurately quantifies bisoprolol in bulk and pharmaceutical formulations. This validated method is fast, sensitive, and suitable for quality control.

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    Area of Science:

    • Analytical Chemistry
    • Pharmaceutical Analysis

    Background:

    • Bisoprolol is a widely used beta-blocker for cardiovascular conditions.
    • Accurate quantification of bisoprolol in pharmaceutical products is crucial for quality control and patient safety.

    Purpose of the Study:

    • To develop and validate a rapid, robust, isocratic reversed-phase high-performance liquid chromatographic (HPLC) method for bisoprolol determination.
    • To ensure the method's suitability for analyzing bisoprolol in both bulk drug substance and finished pharmaceutical formulations.

    Main Methods:

    • Utilized a Zorbax SB-C18 column with a mobile phase of phosphate buffer (pH 3.5) and acetonitrile (70:30) at a flow rate of 1 mL/min.
    • UV detection was set at 225 nm, with column and autosampler temperatures maintained at 25°C.
    • Method validation followed ICH guidelines, assessing linearity, LOD, LOQ, precision, accuracy, recovery, and system suitability, using metoprolol as an internal standard.

    Main Results:

    • Achieved optimal bisoprolol separation with a retention time of 1.158 minutes.
    • Demonstrated linearity in the 5-90 µg/mL range, with LOD of 1.63 µg/mL and LOQ of 4.94 µg/mL.
    • Exhibited high precision (RSD ≤ 2%) and accuracy, with excipients showing no interference in tablet analysis.

    Conclusions:

    • The developed HPLC method is accurate, reproducible, sensitive, and time-efficient.
    • This validated method is suitable for routine quality control of pharmaceutical products containing bisoprolol.