A QbD-GUIDED DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF FEBUXOSTAT
DOI:
https://doi.org/10.63001/tbs.2026.v21.i02.S.I(2).pp745-763Keywords:
RP-HPLC;, Febuxostat;, Quality by Design;, Method Development;, Validation;, Central Composite DesignAbstract
A novel, simple, sensitive, suitable, precise, and powerful RP-HPLC method was developed and
validated for febuxostat, which is of high quality in both bulk and tablet dosage forms.
Chromatographic conditions were optimized using Design Expert software employing a Central
Composite Design (CCD) approach. Separation was carried out with an HPLC system equipped
with Chromeleon 7.3 software and an Agilent Zorbax C18 column (250 mm × 4.6 mm; 5 μm).
Detection was performed at 315 nm. The RP-HPLC method was developed using
acetonitrile:phosphate buffer (50:50 v/v) as the mobile phase at a flow rate of 1.0 mL/min. The
developed method was validated as per ICH Q2(R2) guidelines. The method exhibited excellent
linearity with a correlation coefficient (r²) of 0.9997. The method precision was less than 2.0%
RSD. The percentage recovery for febuxostat was 100.17%. The proposed approach was both
predictive and reliable, demonstrating its suitability for routine quality control analysis of
febuxostat in pharmaceutical formulations.
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