Carbenicillin Indanyl Sodium Tablets
»Carbenicillin Indanyl Sodium Tablets contain the equivalent of not less than 90.0percent and not more than 120.0percent of the labeled amount of carbenicillin (C17H18N2O6S).
Packaging and storage—
Preserve in tight containers.
Identification—
Triturate a quantity of finely powdered Tablets,equivalent to about 100mg of carbenicillin,with 10mLof a solvent mixture consisting of acetone,ethyl acetate,water,pyridine,and glacial acetic acid (200:100:75:25:1.5).Shake the mixture for 5minutes,and dilute 1volume of it with 9volumes of the solvent mixture.Apply 10µLeach of this solution and of a solution of USP Carbenicillin Indanyl Sodium RSin the same solvent mixture containing 1mg of carbenicillin per mLto a suitable thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel mixture.Allow the spots to dry,and develop the chromatogram in a solvent system consisting of a mixture of acetone,ethyl acetate,water,pyridine,and glacial acetic acid (400:300:75:25:2)until the solvent front has moved about three-fourths of the length of the plate.Remove the plate from the chamber,mark the solvent front,and heat the plate at 80
for 30minutes.Allow the plate to cool,and expose it to iodine vapors in a closed chamber for about 30seconds.Spray the plate with a reagent consisting of a 1in 100solution of ferric chloride in 0.1Nhydrochloric acid,potassium ferricyanide solution (1in 100),and methanol (4:4:3):the principal spots from the test solution and the Standard solution are blue on a yellow-green background,and the RFvalue of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution (RFabout 0.5).
for 30minutes.Allow the plate to cool,and expose it to iodine vapors in a closed chamber for about 30seconds.Spray the plate with a reagent consisting of a 1in 100solution of ferric chloride in 0.1Nhydrochloric acid,potassium ferricyanide solution (1in 100),and methanol (4:4:3):the principal spots from the test solution and the Standard solution are blue on a yellow-green background,and the RFvalue of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution (RFabout 0.5).
Dissolution á711ñ—
Medium:
water;900mL.
Apparatus 1:
100rpm.
Time:
45minutes.
Procedure—
Determine the amount of carbenicillin (C17H18N2O6S)equivalent dissolved from the difference between UVabsorbances at the wavelengths of maximum and minimum absorbance at about 267nm and 254nm,respectively,of filtered portions of the solution under test,suitably diluted with water,in comparison with a Standard solution having a known concentration of USP Carbenicillin Indanyl Sodium RSin the same medium.
Tolerances—
Not less than 75%(Q)of the labeled amount of C17H18N2O6Sequivalent is dissolved in 45minutes.
Uniformity of dosage units á905ñ:
meet the requirements.
Water,Method Iá921ñ:
not more than 2.0%.
Assay—
Mobile phase
,Diluting solvent,Standard preparation,and Chromatographic system—Proceed as directed in the Assayunder Carbenicillin Indanyl Sodium.
Assay preparation—
Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 111mg of carbenicillin (C17H18N2O6S),to a 50-mLvolumetric flask,dissolve in Diluting solventwith the aid of sonication,dilute with Diluting solventto volume,and mix.Transfer 10.0mLof this solution to a 100-mLvolumetric flask,dilute with Diluting solventto volume,and mix.
Procedure—
Proceed as directed for Procedurein the Assayunder Carbenicillin Indanyl Sodium.Calculate the quantity,in mg,of carbenicillin (C17H18N2O6S)in the portion of Tablets taken by the formula:
0.5CP(rU/rS),
in which the terms are as defined therein.
Auxiliary Information—
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 346
Phone Number:1-301-816-8335