Analysis method of Cefepime and Tazobactam Injection
01 PURPOSE
To lay down a procedure for analysis of Cefepime and Tazobactum Injection.
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 ml/min
Wave Length : 254 &230nm
Injection Volume : 20ųl
Column temperature : Ambient
Run time : 20min
Buffer
Dissolving 6.8 gm KH2PO4 in 1000ml water
adjust pH 4.0 with KOH or H3PO4
Mobile Phase
Prepare a mixture of Buffer and Methanol in the
Ratio (75:25). Filter through 0.45micron
Standard Preparation : Weight accurately 50.0mg Cefepime and Tazobactum injection
powder WS into 100ml volumetric Flask
and make up with mobile phase
Test Preparation: Weight a quantity of powder containing 50.0mg Cefepime
And Tazobactum in 100 ml volumetric flask make up with mobile
phase and filter
Calculation for Cefepime and Tazobactum
Where :
spl =Average area of major peaks due to Cefepime and
Tazobactum obtained with Test preparation.
std= Average area of major peaks due to Cefepime
Tazobactum standard preparation.
Avg=Average weight
P=Potency of Cefepime and Tazobactum WS.
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