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A stability-indicating HPLC assay method for budesonide.

S Hou1, M Hindle, P R Byron

  • 1Department of Pharmaceutics, Virginia Commonwealth University, Richmond 23298-0533, USA.

Journal of Pharmaceutical and Biomedical Analysis
|February 24, 2001
PubMed
Summary

A new high-performance liquid chromatography (HPLC) method provides specific and stability-indicating analysis for budesonide, accurately detecting impurities and degradation products. This method improves upon existing assays for pharmaceutical quality control.

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Analysis
  • Quality Control

Background:

  • Existing European pharmacopeial and literature-based HPLC assays for budesonide lack specificity and stability-indicating capabilities.
  • These methods fail to accurately qualify budesonide drug substance and identify critical degradation products, particularly in solution.
  • There is a need for a robust analytical method to ensure the quality and stability of budesonide.

Purpose of the Study:

  • To develop and validate a new, stability-indicating HPLC method for budesonide.
  • To assess the specificity and performance of the new method compared to existing assays.
  • To enable accurate impurity profiling and degradation kinetics studies for budesonide.

Main Methods:

  • A novel stability-indicating HPLC method was developed using a Hypersil C18 column.

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  • The mobile phase consisted of ethanol-acetonitrile phosphate buffer (pH 3.4; 25.6 mM) (2:30:68, v/v/v) with UV detection at 240 nm.
  • The method was evaluated using solid-state and solution-stressed budesonide samples, comparing results with pharmacopeial and literature HPLC methods.

    • Main Results:

    • The new HPLC method demonstrated high specificity and stability-indicating capability for budesonide.
    • It successfully separated budesonide epimers, related impurities, and degradation products.
    • The method exhibited linear UV response, good system precision, accuracy, sensitivity, and specificity.

    Conclusions:

    • The developed HPLC method is superior to existing assays for budesonide purity and impurity determination.
    • This novel method provides reliable quantification of budesonide and its degradation products.
    • The method is suitable for future studies on budesonide degradation kinetics and quality control.