Quality by design (QBD) approach to develop stability indicating RP-HPLC method development for naproxen and pantoprazole
Sufiyan Ahmad, Bagul Ashwin, Bakhshi Rahman, Rajshri Gorad, Harshal Tare
Abstract
Background and Objectives: As per requisition of current regulatory requirements, simple, rapid and sensitive method by 33 factorial QbD approach was established and validated for Naproxen (NPX) and Pantoprazole (PPR) by RP-HPLC. Method: A simple RP-HPLC method has been developed and validated with different parameters such as linearity, precision, repeatability, LOD, LOQ, accuracy as per International Conference for Harmonisation guidelines (Q2R1). Statistical data analysis was done for data obtained from different aliquots Runs on Agilent Tech. Gradient System with Auto injector, UV (DAD) & Gradient Detector. Results: Equipped with Reverse Phase (Agilent) C18 column (4.6mm x 100mm; 2.5µm), a 20µl injection loop and UV730D Absorbance detector at 239 nm wave length and running chemstation 10.1 software and drugs along with degradants were separated via Methanol: (0.1% OPA) Water (75:25) of pH 3 as mobile phase setting flow rate 0.7 ml/min at ambient temperature. The developed method was found linear over the concentration range of 10-50 μg/ml for NPX and 4-20 μg/ml for PPR while detection and quantitation limit were found to be 0.2375 (ug/mL) and 0.7199 (ug/mL) for NPX and 0.1028 (ug/mL) and 0.3059 (ug/mL) PPR. Conclusion: There are no interfering peaks underperformed degradation conditions.