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Development of an HPLC Method for Quality Control of Bisoprolol and Its Locally Marketed Pharmaceutical Formulations in Comparison with the Original Product

Doctor Yousuf Al Ahmad

 

Abstract:

In this study, a high-performance liquid chromatography (HPLC) method utilizing ion-pairing technique was developed and validated for the quantitative analysis of bisoprolol in its raw materials and pharmaceutical formulations. An ion-pairing reagent was employed for the first time for this purpose. Chromatographic analysis of the raw material was conducted under the following conditions: a mobile phase consisting of acetonitrile:water in a 50:50 ratio containing 0.001 M sodium heptane sulfonate; an Inertsil ODS-3 column (5 µm, 4.6 × 250 mm); a detection wavelength of 223 nm; and a flow rate of 1.5 mL/min. Under these conditions, the developed method yielded a short retention time of 3.5 minutes, enabling the analysis of a larger number of samples within a relatively short period.
The method's validity was assessed based on parameters of linearity, accuracy, precision, and specificity in accordance with the guidelines of the International Council for Harmonisation (ICH). Linearity was established over the concentration range of 0.02–0.06 mg/mL, with mean recovery values falling within the acceptable range (98–102%). Precision was evaluated in terms of relative standard deviation (RSD%), which was found to be within acceptable limits (less than 2%). Specificity was confirmed by injecting pharmaceutical formulations containing the active ingredient and its excipients. The method demonstrated high sensitivity, achieving a quantitation limit of 0.004 mg/mL and a detection limit of 0.001 mg/mL.

 

Name of the journal in which the research is published:

Homs University Journal.

 

Publication Date:

2022.

 

Link:

Development of an HPLC Method for Quality Control of Bisoprolol and Its Locally Marketed Pharmaceutical Formulations in Comparison with the Original Product