Analytical Method Development and Validation of Linezolidine – A Review

Stability indicating RP-HPLC method has been developed and subsequently validated for the determination of Linezolid. The proposed RP-HPLC method utilizes Phenomenex Luna C18 (250×4.6×5μm) at 300C and mobile phase consisting of buffer: methanol (65: 35 v/v) at a flow rate 1.5 ml/min. Linezolid was separated in less than 60 minutes with good resolution and minimal tailing, without interference of exicipients. The method was validated according to ICH guidelines. All validation parameters were within the acceptable range. The linear regression analysis data for calibration plots shows good linear relationship with R=0.999 in the concentration range of 1–6 μg/ml for a Linezolid. The limit of detection and limit for quantitation for Linezolid were found to be of 0.15 μg/ml and 0.4μg/ml. Intraday and Interday precision (% relative standard deviation) is less than 2%. The method shows the % recovery of Linezolid 96.5–115.1%. The drug is subjected to totally different stress conditions and therefore the ensuing degradation merchandise obtained didn't interfere with the detection of Linezolid and the assay is thus stability indicating.