Development and Optimisation of a Stability-Indicating Analytical Method for Itraconazole in Drug Product by...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Existing methods for itraconazole (ITZ) analysis are time-consuming.
• Separate methods are often required for ITZ and its impurities.
• Compendial methods can have lengthy run times.

Purpose of the Study:

• Develop a single, efficient HPLC method for ITZ quantification.
• Simultaneously quantify ITZ degradation products and impurities.
• Improve upon existing analytical methods for ITZ analysis.

Main Methods:

• Initial screening based on compendial methods.
• Optimization using Design of Experiments (DoE) and Minitab®.
• Pre-validation assessment including selectivity, linearity, and system suitability.

Main Results:

• An isocratic mobile phase (acetonitrile and ammonium phosphate buffer) was used.
• A Poroshell EC-C18 column provided optimal separation.
• The method achieved a 15-minute total run time for ITZ and related substances.

Conclusions:

• The developed HPLC method is faster than compendial approaches.
• The method demonstrates enhanced environmental sustainability.
• The validated method offers improved analytical performance for ITZ.