QbD APPROACH FOR ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BISOPROLOL FUMARATE BY SPECTROSCOPIC METHOD

Author(s): Bhusnure O. G*, Dongare R.B, Gholve S.B, Munde Anoop B, Shette R.S

Abstract: An accurate and reliable ultra-violet spectrophotometric method was developed based on the Quality by Design framework, for determination of Bisoprolol Fumarate oral dosage form. According to International Conference on Harmonization (ICH Q8 [R2]) guidelines, an experimental work was planned for both spectroscopic method development and its validation. QbD (Quality-by-Design) approach was implemented for spectroscopic method development and its validation. The research work demonstrated that the UV is valid for the determination of assay of Bisoprolol fumarate. For performing experimental work analytical grade chemical (water, methanol, chloroform, ethanol) was used the spectroscopic method development and validated on UV spectrophotometer by using suitable solvent (water, methanol, chloroform, ethanol) and detection was performed at 223 nm. Target Product Quality Profile (TPQP) and Critical Quality Attributes (CQA). This is helpful to observe the impact of raw materials Critical Material Attributes (CMA), Critical Process Parameter (CPP) on the CQAs. For all the variable parameters as stated in Ishikawa diagram, the absorbance was recorded over the concentration range.

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