Fast RP-HPLC Method for the Determination of Bisoprolol

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.