Development and validation of the RP-HPLC method for quantification of tavaborole

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Accurate quantification of antifungal agents like tavaborole is crucial for pharmaceutical quality control.
• Developing stability-indicating methods is essential to assess drug degradation under various conditions.

Purpose of the Study:

• To develop and validate a stability-indicating high-performance liquid chromatography (HPLC) method for the precise quantification of tavaborole.
• To optimize chromatographic conditions for sensitive and robust tavaborole analysis.

Main Methods:

• Method development involved optimizing detection wavelength, mobile phase composition (buffer:acetonitrile, 75:25 v/v), column type, and temperature (35 °C).
• Validation included assessing linearity (5-1000 ppm, r²=1.00000), capacity factor (k=3.43), forced degradation studies, and analytical solution stability.
• Orthophosphoric acid was used to adjust buffer pH to 3.0, with a flow rate of 1 mL/min and injection volume of 15 μL.

Main Results:

• The developed HPLC method demonstrated excellent linearity, accuracy, precision, and robustness.
• Forced degradation studies confirmed the method's ability to separate tavaborole from its degradation products.
• Analytical solution stability was confirmed for up to 35 hours at 5 °C.

Conclusions:

• The validated stability-indicating HPLC method provides a reliable approach for tavaborole quantification.
• This method is suitable for routine quality control and stability testing of tavaborole in pharmaceutical formulations.