analysis method of Linezolid Dry Syrup
To lay down a procedure for analysis of Linezolid Dry Syrup
This STP is applicable to Quality Control in formulation plant
QC. Officer /Head-quality Control
Column : C18, 250×4.6mm, 5ųm
Flow Rate : 1.2 ml/min
Wave Length : 254 nm
Injection Volume : 20ųl
Column temperature : Ambient
Run time : 10 min
Buffer Dissolving 2.8ml of acetic acid in 500 ml water
Mobile Phase Prepare a mixture Buffer ,and acetonitrile in the
Ratio (50:50). Filter through 0.45micron
Standard Preparation: Weight accurately 60mg Linezolid WS into 100 ml volumetric
Flask. Dilute 10.0ml of the solution to 50.0 ml with water.
Test Preparation Weight suspension equivalent to 60 mg in 100ml volumetric flask.
Dilute 10.0ml of the solution to 50.0 ml with water.
System Suitability: Separately inject 20.0µl of the standard prepration in five replicate
Injections into the liquid chromatograph and record the chromatograms.
Check the theoretical plates, tailing factors.The theoretical plates should
not less than 9450 and tailing factors should not more than 1.50 and the
relative standard deviation for replicate injections is note more 2.0 percent
Calculation of Rosvastatin Calcium
Au =Average area of major peaks due to Linezolid obtained with
As= Average area of major peaks due to Linezolid obtained with
P=Potency of Linezolid WS.