No,I did not.But I studied about it. You may follow this protocol while developing:

1. Understand Drug Properties: Analyze ketoconazole's solubility, pKa, and pH dependency.

2. Select Medium: Choose buffers (e.g., acidic pH) based on solubility and physiological relevance.

3. Establish Sink Conditions: Ensure the medium can dissolve at least 3x the drug dose.

4. Optimize Parameters: Adjust pH, agitation speed, and USP apparatus.

5. Validate Method: Test discriminatory power, reproducibility, and formulation variability.

Hi, looking at the molecule these are my suggestions. Let me know which one is working for you.

Ketoconazole is a weak dibasic agent and requires acidic media for dissolution and absorption. Tmax is 1 to 2 hours, following oral administration of a single 200 mg dose after meal.

Looking at this following condition may help for discrimination. Change in one dissolution parameter at a time should work

1) Dissolution media of pH 1.2 to pH 3

2) SGF + Enzyme

3) 100 RPM Vs 50RPM paddle speed

4) Media volume 0f 500 ml instead of 800 ml may help

5) Paddle Vs Basket at low RPM in Acidic media

Thanks

Saroj Rout Thank you for your input. What if discrimination is done on the media with a pH of 4.5 + SLS (sodium lauryl sulfate)? Do you think that could be one of the options to consider?