Development and application of an HPLC method for erlotinib protein binding studies

Area of Science:

• Analytical Chemistry
• Pharmacokinetics
• Biochemistry

Background:

• Erlotinib hydrochloride is a crucial therapeutic agent.
• Accurate quantification is essential for pharmacokinetic and protein binding studies.
• Existing methods may lack the required speed or simplicity.

Purpose of the Study:

• To develop a simple, rapid, and accurate reversed-phase high-performance liquid chromatographic (HPLC) method.
• To quantify erlotinib hydrochloride using UV detection.
• To establish a method applicable for protein binding studies.

Main Methods:

• Ultrafiltration was employed for protein binding assays.
• A reversed-phase HPLC method with UV detection at 332 nm was developed.
• The mobile phase consisted of methanol, acetonitrile, and potassium dihydrogen phosphate buffer (15:45:40 %v/v) at a flow rate of 1.3 mL/min.

Main Results:

• The HPLC method achieved a run time of approximately 6 minutes.
• Linearity was observed over the concentration range of 320-20000 ng/mL.
• Intra-day and inter-day precision were below 10%, with accuracies ranging from 97.20% to 104.83%.

Conclusions:

• A simple, accurate, and precise reversed-phase isocratic HPLC method with UV detection was successfully optimized and validated.
• The developed method is suitable for determining erlotinib hydrochloride in biological samples.
• This method provides a reliable tool for protein binding studies of erlotinib hydrochloride.