Development of an Analytical Quality by Design RP-HPLC Method and Its Validation for Estimation of Gefitinib From Bulk, Tablet Dosage Form, and Complex Nanoformulation.

The analytical approach was designed and quantified using a quality-by-design approach to make the RP-HPLC method more robust and efficient for the estimation of analytes from complex nanoformulations. The method is also useful to eliminate the interfering molecule during estimation by employing co-processing steps. The developed method saves time and cost of solvent and employs QbD as a requirement of recent regulatory concern.