CHEMOMETRICS ASSISTED METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING LIQUID CHROMATOGRAPHY METHOD FOR THE ESTIMATION OF BUDESONIDE IN DOSAGE FORMULATION
Vishnu Vardhana Rao G., V. Srinivasa Rao and K. Ramakrishna*
ABSTRACT
Development and validation of a novel and sensitive high performance liquid chromatography method for the estimation of Budesonide (BDS) in tablet dosage form was established by using quality by design approach (QbD). The development activity is focused by the LC technique by UV detection using base deactivated columns.Validation procedure is intended and accomplished as per International Conference on Harmonization (ICH) guidelines. The method uses a Thermo Hypersil BDS C18, 150 x 4.6 mm, 3.0 μm column in isocratic elution with a mobile phase consisting pH 3.2 Monobasic sodium phosphate buffer, Acetonitrile and Ethanol (68:32:02 v/v). All the experiments are carried out in column temperature 400C column oven temperature with UV detection at 246 nm. The eluent used for the extraction of the drug consists of pH 3.2 Monobasic sodium phosphate buffer, Acetonitrile and Methanol (50:25:25 v/v). The method is validated for its specificity, linearity, accuracy, precision, Solution stability and robustness. Design expert linear model was applied and a 24 full factorial design was applied to evaluate coefficient, ANOVA and also establish the robustness of the method.
Keywords: Budesonide, Liquid Chromatography (LC), Validation, International Conference on Harmonization (ICH), Quality by Design (QbD), ANOVA
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