Development of an Analytical Quality by Design RP-HPLC Method and Its Validation for Estimation of Gefitinib From...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Sciences
• Drug Development

Background:

• Accurate drug estimation is crucial for formulation development.
• Gefitinib (GF) is an anticancer drug with poor solubility challenges.
• Analytical scientists require robust methods for drug quantification.

Purpose of the Study:

• Develop innovative Quality by Design (QbD) methods for gefitinib (GF) estimation.
• Quantify GF in bulk, pharmaceutical tablet formulations, and complex nanoformulations.
• Enhance analytical method robustness and efficiency for poorly soluble drugs.

Main Methods:

• Employed Response Surface Methodology (RSM) with Box-Behnken design (BBD) for optimization.
• Screened independent factors (buffer %, pH, flow rate) and dependent responses (plate count, retention time, tailing factor).
• Utilized co-processed steps for analyte estimation in complex formulations.

Main Results:

• Developed a rapid RP-HPLC method ( < 4.5 min) using QbD.
• Achieved high sensitivity and robustness with relative standard deviation < 2%.
• Identified optimal conditions: 60% buffer, pH 4.25, 0.7 mL/min flow rate for maximum desirability (R²=0.998).

Conclusions:

• The QbD approach successfully designed and validated a robust method for GF estimation.
• The method is suitable for formulation scientists to determine drug concentration and release profiles.
• The validated method is efficient, cost-effective, and meets regulatory QbD requirements.