A Novel Stability Indicating Reversed-Phase Liquid Chromatography System for Estimation of Fenofibrate in Bulk and Pharmaceutical Dosage Forms: Comparative Studies with InternalStandard Rosuvastatin

Abstract

Introduction: Fenofibrate (FFB) is an anti-hyperlipidemic treatment that acts by lowering the lipid levels. A new
constancy representing reversed-phase ultra-fast liquid chromatography system was planned for the evaluation of
FFB within comparison to internal reference rosuvastatin (RS) calcium in pharmaceutical preparations. Materials
and Methods: Mobile phase with a composition of 0.1% formic acid and acetonitrile with pace 0.8 mL/min has been
utilized for analyze of FFB in existence of inner standard RS calcium. Forced degradation experiments were conducted
by subjecting FFB to a range of stress environments, including acidic, oxidative, basic, and thermal circumstances,
to assess the stability that indicates efficacy of the technique. Results: Analytical procedure demonstrated excellent
linearity across the concentration interval of 0.5–50 μg/mL, described by the regression formula y = 0.1281x−00.0081
thru a correlation coefficient (R2) of 0.9998. The method exhibited high sensitivity, with the limit of quantification
determined as 0.4327 μg/mL and limits of detection calculated as 0.1427 μg/mL. Conclusion: Overall, the validated
technique demonstrated as reliable and appropriate for monotonous quantitative examination of FFB in tablet dosage
forms, fulfilling all acceptance criteria specified under International Council for Harmonisation validation guidelines.