Chromatographic System
:
Column :
25cm x 4.6mm, packed with particles of silica(5µm)
Flow rate :
1.2ml / minute , so that the resolution factors between the peaks corresponding to the Cefuroxime axetil
diastereoisomers A & B in solution(4)and
between the peaks corresponding to Cefuroxime axetil diastereoisomer A &
the Cefuroxime axetil A³ -isomer in
solution (2) are each not less than 1.5.
Wavelength :
278nm
Temperature :Ambient
Injection volume :
20µL
Mobile Phase :
A mixture of 38 volumes of Methanol & 62 volumes of
0.2M Ammonium dihydrogen orthophosphate.
Solution (1) :- Disperse 10 tablets in 0.2M Ammonium Dihydrogen
Orthophosphate
previously adjusted to pH 2.4 with Orthophosphoric acid using
10ml per gm of the stated content of cefuroxime . Immediately add sufficient
methanol to produce a solution containing the equivalent to 0.5%w/v of
cefuroxime and shake vigorously.
Filter and dilute a quantity of the filtrate with sufficient
mobile phase to produce a
solution containing the equivalent to 0.025% w/v of
cefuroxime.
Solution (2) :- Heat a quantity of solution(1) at
600 C for 1hour or until sufficient impurities ( 0 -isomers) have been generated.
Solution (3) :- Expose a quantity of solution(1) to ultraviolet
light (254nm) for 24 hours or
until sufficient impurities (E-isomers) have been generated. Solution (4) contains 0.03% w/v of Cefuroxime Axetil CRS in mobile
phase.
All solutions
containing Cefuroxime Axetil, if not to be used for immediate
analysis, should be
stored in the dark at a temperature 2º & 8º before analysis.
The retention times relative to Cefuroxime axetil
diastereoisomer A are approximately 0.9 for Cefuroxime axetil diastereoisomer B
, 1.2 for the Cefuroxime
axetil A³-isomers and
1.7 & 2.1 for E-isomers .The relative standard deviation for the
response factor of Cefuroxime axetil for replicate injections
of solution (1) is not more than 2.0%.
Calculate the content of C20H22N4O10S
as the sum of the areas of the two peaks
corresponding to diastereoisomers A & B of Cefuroxime axetil using
the declared
Content of C20H22N4O10S
in Cefuroxime axetil CRS. Each mg of Cefuroxime axetil
Is equivalent to 0.8313mg Cefuroxime.
