Quality control of protease inhibitors

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Virology

Background:

• Protease inhibitors (PIs) are key antiretroviral drugs for managing HIV/AIDS.
• Ten PIs have received FDA approval for HIV treatment.
• PIs are typically used in combination therapy.

Purpose of the Study:

• To review quality control methods for FDA-approved PIs.
• To summarize analytical techniques, with a focus on LC methods.
• To provide a literature-based overview of PI analysis.

Main Methods:

• Literature search for analytical techniques used in PI quality control.
• Focus on liquid chromatography (LC) methods.
• Analysis of methods for both drug substances and finished products.

Main Results:

• Various analytical techniques are employed for PI quality control.
• LC methods are extensively described in the literature for PI analysis.
• The review covers methods for drug substance and product analysis.

Conclusions:

• Robust analytical methods are essential for ensuring the quality of PIs.
• LC techniques are vital for the quality control and analysis of HIV protease inhibitors.
• This review consolidates current analytical approaches for PIs.