Dissolution á711ñ
Medium:
0.05Mpotassium phosphate buffer,pH7.2,prepared by dissolving 6.8g of monobasic potassium phosphate in 1000mLof water and adjusting with 1Nsodium hydroxide to a pHof 7.2;900mL.
Apparatus 1:
100rpm.
Time:
45minutes.
Procedure
Determine the amount of cefixime (C
16H
15N
5O
7S
2)dissolved from UVabsorbances at the wavelength of maximum absorbance at about 288nm of filtered portions of the solution under test,suitably diluted with
Dissolution Mediumif necessary,in comparison with a Standard solution having a known concentration of
USP Cefixime RSin the same medium.
[NOTEAn amount of methanol not to exceed 0.1%of the total volume of the Standard solution may be used to bring the Reference Standard into solution prior to dilution with
Dissolution Medium,and the solution may be sonicated to assure complete dissolution of the Reference Standard.
]
Tolerances
Not less than 75%(Q)of the labeled amount of cefixime (C16H15N5O7S2)is dissolved in 45minutes.
Assay
Tetrabutylammonium hydroxide solution,Mobile phase,pH7.0Phosphate buffer,Resolution solution,Standard preparation,and Chromatographic system
Proceed as directed in the
Assayunder
Cefixime.
Assay preparation
Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 400mg of cefixime,to a 100-mLvolumetric flask,add 75mLof pH7.0Phosphate buffer,and sonicate.Dilute with pH7.0Phosphate bufferto volume,mix,and centrifuge.Transfer 5.0mLof the clear supernatant to a second 100-mLvolumetric flask,dilute with pH7.0Phosphate bufferto volume,and mix.
Procedure
Proceed as directed in the
Assayunder
Cefixime.Calculate the quantity,in mg,of cefixime (C
16H
15N
5O
7S
2)in the portion of Tablets taken by the formula:
2000C(rU/rS),
in which the terms are as defined therein.