ABSTRACT

A novel simple isocratic RP-HPLC method has been developed for the estimation of Budesonide (BN) And Formoterol (FT) API and Its formulation. Chromatographic separation was achieved in an isocratic elution mode by QBD-approach. Quality by Design approach to method development uses statistical design of experiments to develop a robust method ‘design space’. The design space defines the experimental region in which changes to method parameters will not significantly affect the results. The present study describes the development of a comprehensive science and risk based HPLC method and subsequent validation for the analysis of BN and FT drug substances and drug products using a quality by design approach. The optimal chromatographic separation was achieved using Methanol and 0.1% OPA in ratio of 30:70 v/v (pH 4.5 adjusted with TEA) as the mobile phase with a flow rate of 1 mL/min by using a DAD detector at 231 nm. The developed method was validated as per international conference on Harmonization guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and ruggedness. Keywords: Budesonide, Formoterol, Quality By Design approach, Design of Experiments, RP-HPLC
Publication date: 01/02/2022

https://ijbpas.com/pdf/2022/February/MS_IJBPAS_2022_5916.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.2.5916