A Rapid, Stability Indicating RP-UPLC Method for Simultaneous Determination of Ambroxol Hydrochloride, Cetirizine Hydrochloride and Antimicrobial Preservatives in Liquid Pharmaceutical Formulation
2011

Rapid Method for Measuring Ambroxol and Cetirizine in Liquid Formulations

publication 10 minutes Evidence: high

Author Information

Author(s): Trivedi Rakshit Kanubhai, Patel Mukesh C., Jadhav Sushant B.

Primary Institution: Dr. Reddy’s Laboratories Ltd.

Hypothesis

A new RP-UPLC method can effectively measure ambroxol hydrochloride, cetirizine hydrochloride, and their preservatives in liquid pharmaceutical formulations.

Conclusion

The developed RP-UPLC method is effective for the rapid and simultaneous estimation of ambroxol, cetirizine, and their preservatives in liquid formulations.

Supporting Evidence

  • The method was validated according to ICH guidelines.
  • Forced degradation studies confirmed the method's specificity.
  • The run time for the analysis is only 3.5 minutes.

Takeaway

Scientists created a quick way to check if certain medicines are in liquid form, making it easier to ensure they are safe and effective.

Methodology

The method uses RP-UPLC with gradient elution to separate and quantify ambroxol, cetirizine, methylparaben, and propylparaben in liquid formulations.

Limitations

The method may not be applicable to all types of pharmaceutical formulations beyond those tested.

Digital Object Identifier (DOI)

10.3797/scipharm.1103-19

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