Abstract
This work intends to develop a QbD-based RP-HPLC method and validate rutin (RU) and ascorbic acid (ASC) in combined tablet dosage form. The method is optimized by the central composite design. The independent variables chosen are mobile phase ratio and pH. The dependent variables are retention time for RU (R1), retention time for ascorbic acid ASC (R2), and resolution (R3). Analysis of variance revealed that the method parameters were significant (p <5). Waters Alliance-e2695 [C18 (150x 4.6 mm, 3.5)] was used to separate rutin and ascorbic acid using a mobile phase Acetonitrile: Hexane Sulphonic Acid (pH-2.5/OPA) in a 70:30 ratio, the selected wavelength was 215 nm. Method validation and degradation studies were performed ICH guidelines are followed. The approach was determined to be easy, suitable, accurate, precise, and robust for quantitative analysis of ascorbic acid and rutin.
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