What question did this study set out to answer?

This research aims to develop and validate a robust RP-HPLC method for Etifoxine Hydrochloride employing a Quality by Design (QbD) framework.

March 28, 2026Open Access

Central Composite Design Based QBD Approach for the Development and Validation of a Rp-HPLC Method for Etifoxine Hydrochloride.

Key Points

This research aims to develop and validate a robust RP-HPLC method for Etifoxine Hydrochloride employing a Quality by Design (QbD) framework.
Utilized a Central Composite Design (CCD) to optimize method parameters like mobile phase composition, flow rate, and column temperature.
Achieved chromatographic separation using a C18 column and a specific mobile phase composition.
Conducted method validation following ICH Q2(R2) guidelines.
Optimized method parameters resulted in a retention time of 3.164 minutes.
Achieved linearity within the concentration range of 25-75 µg/mL with a high correlation coefficient of 0.99982.
Determined Limit of Detection (LOD) at 3.00 µg/mL and Limit of Quantitation (LOQ) at 9.09 µg/mL with acceptable accuracy of 98-102% and %RSD < 2%.

Abstract

This Study shows the Robust Reverse Phase High Performance Liquid Chromatography method for the development of Etifoxine Hydrochloride using QbD Approach and Central Composite Design. Critical Method Parameters such as Mobile Phase Composition, Flow Rate and Column Temperature are optimized using Central Composite Design (CCD). After optimizing the Method using CCD the Chromatographic Separation was found in C18 Column Cosmosil C18 (250mm × 4.6mm × 5µ) using the mobile phase composition of phosphate buffer (pH 2.3 adjusted by orthophosphoric acid): methanol respectively(15:85%v/v) at a flow rate of 1.01mL/min at detection wavelength at 264nm. The retention time was found at 3.164 min. After this the optimized parameter is validated using the ICH guidelines. Linearity has been performed at the range of Concentration 25-75µg/mL and Correlation Coefficient (R2) was found to be 0.99982. LOD and LOQ was found at 3.00 µg/mL and 9.09 µg/mL respectively. The method is validated using ICH Q2(R2) guideline which shows the acceptable accuracy level (98-102%) and %RSD < 2%. Thus the application of AQbD found understanding of method variability.

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