Stability indicating HPLC method development and validation for quantification of Linezolid oral suspension dosage forms

Abstract Linezolid is a synthetic oxazolidinone antimicrobial agent with activity against gram-positive bacteria. The development of a reliable, sensitive, and specific HPLC method for quantifying Linezolid in oral suspension formulations provides a treatment option for patients who require liquid dosage forms. A simple and reliable stability indicating HPLC method was developed for the quantification of Linezolid in oral suspension. To develop and validate a simple and effective HPLC method for the quantification of Linezolid in oral suspension. Quantification of Linezolid was performed using a reverse-phase (RP) HPLC system equipped with a Hypersil BDS C18 column (150 mm × 4.6 mm, 5 µm), with UV detection at 254 nm and a flow rate of 0.8 mL/min. The column temperature was maintained at 30°C. The proposed method was validated in accordance with current regulatory guidelines. The correlation coefficient for Linezolid was found to be greater than 0.999, indicating excellent linearity. Method precision and accuracy were confirmed, with intra- and inter-day relative standard deviation (RSD) values ranging from 0.36–0.42%. Linezolid recovery values ranged from 99.7–100.4%, demonstrating the method's accuracy. The stability of both standard and sample solutions were established for up to 72 hours under the specified conditions. A robust and reliable stability indicating HPLC method developed for the quantification of Linezolid in oral suspension. The proposed article is the first RP-HPLC method for the quantification of Linezolid in oral suspension.