A new RP-HPLC approach for estimation of potential impurities of Fosamprenavir - method development and validation

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Fosamprenavir is an essential antiretroviral drug.
• Accurate quantification of impurities is crucial for drug safety and efficacy.
• Existing analytical methods may lack the required sensitivity or efficiency.

Purpose of the Study:

• To develop and validate a robust reversed-phase high-performance liquid chromatography (RP-HPLC) method.
• To achieve efficient separation and quantification of Fosamprenavir and its key impurities.
• To establish a reliable method for routine drug quality control.

Main Methods:

• Utilized a Zobrax C18 column with a gradient elution of water and acetonitrile.
• Employed orthophosphoric acid as a mobile phase additive and UV detection at 264 nm.
• Validated the method according to International Council for Harmonisation (ICH) Q2(R1) guidelines.

Main Results:

• Achieved separation of Fosamprenavir, Amprenavir, and impurities (isomer, amino, propyl, nitro) within a 10-minute run time.
• Demonstrated excellent linearity (R² = 0.999), precision (% RSD: 0.5-1.7), and accuracy (% recovery: 90.9-104.3%).
• The method showed high sensitivity (LOD/LOQ), specificity, and robustness.

Conclusions:

• The developed RP-HPLC method is reliable, sensitive, and efficient for analyzing Fosamprenavir and its impurities.
• This novel method surpasses existing techniques in speed and performance.
• The validated method supports stringent drug quality monitoring and regulatory compliance.