Cefpodoxime Proxetil Tablets
» Cefpodoxime Proxetil Tablets contain an amount of Cefpodoxime Proxetil equivalent to not less than 90.0 percent and not more than 110.0 percent of the labeled amount of cefpodoxime (C15H17N5O6S2).
Packaging and storage Preserve in tight containers, at controlled room temperature.
USP Reference standards 11
Identification The retention times of the cefpodoxime proxetil R-epimer peak and the cefpodoxime proxetil S-epimer peak in the chromatogram of the Assay preparation correspond to those in the chromatogram of the Standard preparation, as obtained in the Assay.
Medium Dissolve 54.5 g of glycine and 42.6 g of sodium chloride in about 500 mL of water in a 1000-mL volumetric flask. Cautiously add, with swirling, 14.2 mL of hydrochloric acid, and allow to cool. Dilute with water to volume, and mix. Transfer 50 mL of this stock solution to a flask, and dilute with water to 900 mL to obtain a solution having a pH of 3.0 ± 0.1. [noteIf necessary, adjust the pH of the stock solution with 10 N sodium hydroxide so that when 50 mL is diluted with water to 900 mL the pH of the Dissolution Medium is 3.0 ± 0.1. ]
Apparatus 2: 75 rpm.
Time: 30 minutes.
Procedure Determine the amount of cefpodoxime (C15H17N5O6S2) dissolved by employing UV absorption at about 259 nm on filtered portions of the solution under test in comparison with a Standard solution having a known concentration of USP Cefpodoxime Proxetil RS prepared by dissolving an accurately weighed portion in a small volume of methanol and diluting quantitatively with Dissolution Medium.
Tolerances Not less than 70% (Q) of the labeled amount of cefpodoxime (C15H17N5O6S2) is dissolved in 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Water 921: not more than 5.0%.
Mobile phase, Diluent, and Chromatographic system Prepare as directed in the Assay under Cefpodoxime Proxetil.
Standard preparation Transfer about 30 mg of USP Cefpodoxime Proxetil RS, accurately weighed, to a 50-mL volumetric flask, dissolve in 5 mL of methanol, dilute with Diluent to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, dilute with Diluent to volume, and mix. Pass through a filter having a 0.45-µm or finer porosity.
Assay preparation Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 50 mg of cefpodoxime to a 100-mL volumetric flask. Dissolve in 40 mL of Diluent, sonicating for 5 minutes. Cool to room temperature, dilute with Diluent to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, dilute with Diluent to volume, mix, and pass through a filter having a 0.45-µm or finer porosity.
Procedure Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg of cefpodoxime (C15H17N5O6S2) in the portion of Tablets taken by the formula:
2CP(rU / rS)in which C is the concentration, in mg per mL, of USP Cefpodoxime Proxetil RS in the Standard preparation; P is the designated potency, in µg per mg, of cefpodoxime (C15H17N5O6S2) in USP Cefpodoxime Proxetil RS; and rU and rS are the sums of the peak responses for cefpodoxime proxetil S-epimer and cefpodoxime proxetil R-epimer obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2569Pharmacopeial Forum: Volume No. 28(1) Page 49