A QBD based RP-HPLC Method Development and Validation for Quantification of Pregabalin Capsules

This study emphasizes the pivotal role of Quality by Design (QbD) in the development of pharmaceutical methods, with a particular focus on risk assessment to ensure consistent quality. The research showcases the creation of a precise and practical HPLC method for Pregabalin Capsules, developed using QbD principles. This optimized method, designed through a systematic Design of Experiment approach, provides a robust and cost-effective solution for pharmaceutical analysis, promoting the consistent quality required within predefined specifications. The method employs a Neucleosil C-18 column (150 mm x 4.6 mm, 5μM) and employs isocratic elution with a mobile phase composed of Acetonitrile and Phosphate Buffer (pH 6.8) in a 20: 80 v/v ratio. Key method parameters include a flow rate of 0.9 mL/min, a column oven temperature set at 40°C, an injection volume of 20 μL, and UV detection at 210 nm. Rigorous validation following ICH Q 2 (R1) and USP <1225> guidelines ensures the method's reliability, with assessments of parameters such as limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, and robustness. The method's exceptional sensitivity, selectivity, efficiency, precision, accuracy, and cost-effectiveness make it an optimal choice for pharmaceutical analysis of Pregabalin Capsules.