A Simple Development and Validated Reverse Phase-HPLC Method for the Determination of Linezolid in Bulk and Pharmaceutical Dosage Forms

A convenient, simple, accurate, precise and reproducible RP-HPLC method was developed and validated for the estimation of Linezolid in the bulk drug and pharmaceutical dosage form. The objective was achieved under optimized chromatographic conditions on Welchrom C18 isocratic column (250 mm × 4.6 mm, 5 μm) with Shimadzu LC-20AT Prominence Liquid chromatograph. The mobile phase was a mixture of acetonitrile: water 50:50 v/v, with apparent pH of 6.8. The separation was attained using an isocratic elution method with a flow rate of 1.2 mL/min at room temperature. The detection was made at a wavelength of 254nm by using UV- Visible detector.  The retention time for Linezolid molecule was found to be 2.813.The standard calibration plot was linear over a concentration range of 2-10 µg/mL with r2= 1 and the respective linear regression equation being y= 177.1x + 0.030.The limit of detection and limit of quantification were found to be 0.04µg/mL and 0.014µg/mL respectively. The amount of Linezolid presents in the bulk drug 99.81%and in the formulation 99.81% of the stated amount respectively. The method was validated statistically using the %RSD and the values are found to be within the limits. No interference peaks from Excipients and relative retention time indicated the specificity of the Method.  The recovery studies were performed and mean percentage recoveries were found to be greater than 99% with RSD less than 1.0%. So the proposed method was found to be simple, specific, linear, robust and reproducible. Hence this method was conveniently and easily applied for routine analysis of Linezolid in bulk drug and tablet dosage form.