Analysis method of Ceftriaxone Sodium and Sulbactam sodium Injection
01 PURPOSE
To lay down a procedure for analysis of Ceftriaxone Sodium and Sulbactum sodium 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 Ceftriaxone Sodium and
Sulbactum Sod. injection powder WS into 100ml volumetric Flask
and make up with mobile phase
Test Preparation: Weight a quantity of powder containing 50.0mg Ceftriaxone sod.
And Sulbactum Sod. in 100 ml volumetric flask make up with mobile
phase and filter
Calculation for Ceftriaxone and Sulbactum Sod.
Where :
Au =Average area of major peaks due to Ceftriaxone and
Sulbactum Sod. obtained with Test preparation.
As= Average area of major peaks due to Ceftriaxone
Sulbactum Sod.standard preparation.
Avg=Average weight
P=Potency of Ceftriaxone and Sulbactum Sod. WS.
Analysis method of Ceftriaxone Sodium and Sulbactam sodium Injection
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