A Quality by Design (QBD) Approach for the Development and Validation of RP-HPLC Method for the Quantification of Silymarin Tablet

Abstract

This study emphasizes the crucial role of Quality by Design (QbD) in developing pharmaceutical procedures, particularly in risk assessment. It demonstrates how QbD principles were applied to create a precise and effective HPLC method for Silymarin Tablets, ensuring consistent quality within specified criteria. The optimized method, developed using a Design of Experiment approach, employs a C18 column (150 mm x 4.6 mm, 5μm) with isocratic elution using a 95:25 ratio of acetonitrile to orthophosphoric acid buffer (pH 3). Peaks were detected using a PDA detector calibrated at 287 nm, with a flow rate of 1.0 mL/min. The column oven temperature was maintained at 25°C, and a 10 μL injection volume was used. Thorough validation, adhering to USP <1225> and ICH Q2 (R1) standards, ensures the method's reliability. Key factors such as accuracy, precision, robustness, limit of detection (LOD), and limit of quantification (LOQ) were comprehensively assessed. The method exhibits exceptional sensitivity, selectivity, efficiency, precision, accuracy, and cost-effectiveness, making it ideal for pharmaceutical analysis of Silymarin tablets. It has been validated to effectively differentiate between marketed products, including those closely resembling the original. This method is intended for routine quality control analysis in the pharmaceutical industry, highlighting its suitability and reliability for ongoing use.