ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BISOPROLOL FUMARATE BY QBD APPROACH FORM

Author(s): Bhusnure O.G.*, Dongare R. B1, Gholve S.B, Rajmanya T.M.

Abstract: A new approach to drug development could increase efficiencies, provide regulatory relief, flexibility, and offer important business benefits throughout the product’s life cycle. Quality by design is a systemic approach and essential part of the modern approach for quality and pharmaceutical development. It includes defining target product quality profile, designing product, developing formulations, manufacturing processes, identifying critical quality attributes, process parameters, sources of variability and controlling manufacturing processes to ensure consistent product quality over time. Two independent factors were used such as flow rate (A), wavelength (B). Totally 27 experimental runs were suggested by the software for analyzing the interaction of each level on formulation characters and the peak area (R1), tailing factor (5%) (R2) and number of theoretical plates USP (NTP) (R3) were considered as response factors (dependent factors). The significance of independent factors was determined using Fisher’s statistical test for Analysis of the Variance (ANOVA) model that was estimated. Waters cosmosil C-18 column (150 mm × 4.6 mm, 5 µm pore size), column was the most suitable one since it produced symmetrical peaks with better resolution. The UV wavelength was found to be 233 nm showing highest sensitivity of both compounds. The method was validated for specificity, reproducibility, accuracy, linearity, robustness and solution stability and can be used for the assessment of quality of drug product in development and stability samples of the marketed oral tablet. The target degradation for the stability indicating ability of the assay method was tried in the present study and there was no any interfering peaks found due to degradation products.

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