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Related Experiment Videos

UV absorption method should not be applied for determining amoxycillin in acidic dissolution test medium.

T Tokumura1, Y Machida

  • 1Department of Drug Delivery Research, Hoshi University, Ebara 2-4-41, Shinagawa, 142-8501, Tokyo, Japan. tokumura@pep.ne.jp

International Journal of Pharmaceutics
|September 29, 2001
PubMed
Summary

The ultraviolet (UV) method inaccurately measures amoxycillin (AMX) stability in acidic solutions due to degradation interference. High-performance liquid chromatography (HPLC) accurately quantifies AMX degradation, revealing a half-life of 7.04 hours.

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Area of Science:

  • Pharmaceutical analysis
  • Drug stability studies

Background:

  • Amoxycillin (AMX) is a widely used antibiotic.
  • Accurate stability determination is crucial for drug efficacy and safety.
  • Assay method suitability requires rigorous validation, especially for degradation studies.

Purpose of the Study:

  • To evaluate the suitability of ultraviolet (UV) absorption and High-Performance Liquid Chromatography (HPLC) methods for determining amoxycillin (AMX) stability in acidic conditions.
  • To compare the accuracy of UV and HPLC methods in quantifying AMX degradation.
  • To assess the impact of AMX degradation on assay results in dissolution testing.

Main Methods:

  • Stability of amoxycillin (AMX) in acidic solution (pH 1.2) was assessed.
  • Two analytical methods were employed simultaneously: ultraviolet (UV) absorption and HPLC.

Related Experiment Videos

  • Degradation kinetics, including the rate constant and half-life, were determined using HPLC.

    • Main Results:

    • HPLC analysis demonstrated significant degradation of AMX, with a calculated first-order rate constant (k(obs)) of 9.83x10(-2) h(-1) and a half-life of 7.04 hours.
    • UV method data showed an apparent increase in AMX concentration over time, contrary to actual degradation.
    • The increase in UV absorption at 272 nm during AMX degradation led to inaccurate measurements.

    Conclusions:

    • The UV absorption method is unsuitable for quantifying amoxycillin (AMX) in samples undergoing degradation.
    • HPLC provides accurate quantitative data for AMX degradation in acidic environments.
    • UV method should not be used for AMX determination in dissolution tests for sustained-release formulations due to unavoidable acidic conditions and degradation.