analysis method of Linezolid Dry Syrup
01 PURPOSE
To lay down a procedure for analysis of Linezolid Dry Syrup
02 SCOPE
This STP is applicable to Quality Control in formulation plant
03 REFERENCE
In house
04 RESPONSIBILITY
QC. Officer /Head-quality Control
05 ASSAY
Instrumental Conditions:
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
Where :
Au =Average area of major peaks due to Linezolid obtained with
Test preparation.
As= Average area of major peaks due to Linezolid obtained with
standard preparation.
Avg=Average weight
P=Potency of Linezolid WS.
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