QUALITY BY DESIGN STRATEGY FOR DEVELOPMENT AND VALIDATION OF AN RP- HPLC METHOD FOR MARKER-BASED STANDARDIZATION OF FISETIN IN MARKETED HERBAL PREPARATIONS
Abstract
Introduction: This study underscores the importance of QbD in developing pharmaceutical processes, with a strong emphasis on risk assessment. It demonstrates how QbD principles were applied to create a reliable and cost-effective HPLC method for fisetin capsules, ensuring consistent quality within defined criteria. Method: The method, developed through a rigorous Design of Experiment approach, employs an isocratic elution method using a Chemsil ODS-C18 column with a mobile phase composition of 70:30 methanol to 0.1% OPA. Detection of peaks was achieved with a UV detector set at 362 nm, and an optimal flow rate of 1.0 mL/min was determined. The column oven was maintained at an ambient temperature, and the injection volume was set at 10 μL. Result: Thorough validation following ICH Q2 (R1) guidelines verifies the method’s reliability. Key parameters evaluated during this process include linearity, which was established over a range of 10 to 50 μg/mL with an r² value of 0.997; LoD and LoQ, determined to be 2.903 and 8.797 μg/mL, respectively; and precision and robustness, with %RSD values found to be below 2%. Furthermore, accuracy and assay tests were performed, and the results were within the acceptable range as specified by ICH guidelines. Discussion and Conclusion: The method is particularly suitable for analyzing fisetin capsules in the pharmaceutical industry due to its remarkable sensitivity, selectivity, precision and accuracy. Designed for routine pharmaceutical quality control, this method effectively distinguishes between marketed drugs and the innovator product.
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