Central Composite Design Aided Method Development and Validation of a Reverse Phase HPLC Method for Escitalopram in Synthetic Mixture

The goal of this study was to use high-performance liquid chromatography with an Analytical Quality by Design (AQbD). The experiment was performed on a Methanol: Water HPLC system equipped with a Raptor C-18 column. To achieve chromatographic separation, a mobile phase of Triethylamine buffer (0.05%; pH 3.0) and Ortho Phosphoric acid in an 80:20 v/v ratio was used with a flow rate of 0.7mL/min for 10 minutes at 235 nm. AQbD was used to optimize chromatographic conditions using a central composite design (CCD). A factorial design of 17 (three factors and three responses) was used with StatEase Inc.'s Design Expert 10.0.1 software. The HPLC method was validated using ICH, and it met all acceptance criteria. In the dilution range of 10to60μg/mL, the procedure was shown to be linear. HPLC method development and validation for tablet dosage form qualitative determination of antidepressants and antipsychotic drugs in a respective manner.