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Stress studies on acyclovir.

V R Sinha1, , A Trehan

  • 1University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, India. vr_sinha@yahoo.com

Journal of Chromatographic Science
|July 14, 2007
PubMed
Summary
This summary is machine-generated.

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Acyclovir, an antiviral, degrades significantly under acidic and oxidative conditions but remains stable to heat. A validated stability-indicating HPLC method was developed to analyze acyclovir and its degradation products, primarily guanine.

Area of Science:

  • Pharmaceutical Chemistry
  • Analytical Chemistry

Background:

  • Acyclovir is a crucial antiviral medication for various herpes virus infections.
  • Understanding acyclovir's degradation pathways is essential for ensuring drug efficacy and safety.

Purpose of the Study:

  • To investigate the degradation behavior of acyclovir under various stress conditions.
  • To develop and validate a stability-indicating high-performance liquid chromatography (HPLC) method for acyclovir analysis.

Main Methods:

  • Forced degradation studies were conducted under International Conference on Harmonization (ICH) conditions: hydrolysis (acidic, neutral, alkaline), oxidation, photolysis, and thermal decomposition.
  • A stability-indicating HPLC method was developed using a C-18 column with a water-methanol mobile phase (90:10), a flow rate of 1 mL/min, and detection at 252 nm.

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  • The HPLC method was validated for linearity, precision, accuracy, selectivity, specificity, and robustness.

    • Main Results:

    • Acyclovir exhibited extensive degradation in acidic conditions and oxidative stress.
    • Mild degradation was observed in neutral and alkaline conditions.
    • The drug was stable to dry heat and photolysis in solid form, but degraded in aqueous solution upon light exposure.
    • Guanine was identified as the major degradation product under acidic hydrolysis and photolysis.
    • The developed HPLC method demonstrated excellent linearity (correlation coefficient 0.9998), precision (RSD < 2%), and accuracy (recovery 97.34%–102.35%).

    Conclusions:

    • A validated stability-indicating HPLC method was successfully developed for acyclovir.
    • The method is suitable for analyzing acyclovir in various stability studies and pharmaceutical formulations.
    • Understanding acyclovir's degradation profile aids in formulation development and storage recommendations.