Simple and Rapid HPLC Method for the Quantification of Irbesartan in Rat Biological Matrices Development and Bioanalytical Validation

Abstract

Objective: Irbesartan is one of the expansively utilized angiotensin II receptor blockers for treatment of hypertension and diabetic nephropathy. Accurate pharmacokinetic evaluation of irbesartan requires sensitive and trustworthy analytical methods. This study successfully established and thoroughly validated a novel and quick Ultra-Fast Liquid Chromatography (UFLC) bioanalytical method for the measurement of Irbesartan in rat plasma as a pure bulk medication.
Methods: Using an isocratic mobile phase consisting of methanol and PBS (pH 3.5) in an 80:20 (v/v) ratio, the chromatographic separation was successfully accomplished on a C18 column (4.6 × 250 mm, 5 μm) at room temperature.
Results: UV detection was tracked at 233 nm, and the flow rate was 0.75 mL/min. In the absence of endogenous plasma interference, a distinct, sharp analyte peak was seen at a retention time of 6.4minutes. Over a broad concentration range of 100–7000 ng/mL, the technique demonstrated high linearity. Additionally, good extraction recovery (mean ~95.5%), outstanding accuracy, intra-day and inter-day precision, and high stability under various storage conditions and bioanalytical study were attained through stringent validation.
Conclusion: In conclusion, a simple, rapid, and sensitive isocratic UFLC method was effectively developed and fully validated for the quantification of Irbesartan in rat plasma. The method exhibited high selectivity, excellent recovery (95.5%), robust stability under varied storage conditions, and low detection limits across a wide dynamic range (100–7000 ng/mL). Meeting all regulatory validation measures, this analytical approach aids as a reliable, cost-effective, and high throughput platform for routine preclinical pharmacokinetic, bioavailability, and bioequivalence evaluations of Irbesartan. Finally, the method works well for standard bioanalytical applications.