Stability indicating High Performance Liquid Chromatography method development and validation for quantification of Linezolid oral suspension dosage forms

Background: 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.

Objective: To develop and validate a simple and effective HPLC method for the quantification of Linezolid in oral suspension.

Methods: Quantification of Linezolid was performed using a reverse-phase (RP) HPLC sys-tem 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.

Results: 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 excel-lent linearity. Method precision and accuracy were confirmed, with intra- and inter-day relative standard deviation (RSD) values ranging from 0.36% to 0.42%. Linezolid recovery values ranged from 99.7% to 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 condi-tions.
Conclusions: A robust and reliable stability indicating HPLC method developed for the quanti-fication of Linezolid in oral suspension.

KEYWORDS: Linezolid, HPLC, Stability-indicating method, Method development, Method validation, Oral suspension, Quantification, Pharmaceutical dosage form, ICH guidelines, Forced degradation study