Cefixime for Oral Suspension
Cefixime for Oral Suspension is a dry mixture of Cefixime and one or more suitable diluents, flavors, preservatives, and suspending agents. It contains the equivalent of NLT 90.0% and NMT 120.0% of the labeled amount of cefixime (C16H15N5O7S2)/mL when constituted as directed in the labeling.
• The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Solution A: 0.4 M tetrabutylammonium hydroxide solution and water (1:39). Adjust with 1.5 M phosphoric acid to a pH of 6.5.
Solution B: 13.6 mg/mL of monobasic potassium phosphate
Solution C: 14.2 mg/mL of anhydrous dibasic sodium phosphate. Adjust a volume of this solution with a sufficient volume of Solution B to a pH of 7.0.
Mobile phase: Acetonitrile and Solution A (1:3)
System suitability solution: 1 mg/mL of USP Cefixime RS. [NoteHeat this solution at 95 in an oil bath for 45 min, cool, and use promptly. ]
Standard solution: 0.2 mg/mL of USP Cefixime RS in Solution C. [NoteUse this solution promptly. ]
Sample solution: Constitute Cefixime for Oral Suspension as directed in the labeling. Quantitatively dilute a suitable aliquot of the suspension, freshly mixed and free from air bubbles, with Solution C to obtain a solution having a nominal concentration of 0.2 mg of cefixime/mL.
Detector: UV 254 nm
Column: 4.6-mm × 12.5-cm; 4-µm packing L1
Flow rate: Adjust flow rate so that the retention time of cefexime is about 10 min.
Injection size: 10 µL
Samples: System suitability solution and Standard solution
[NoteThe relative retention times for cefixime (E)-isomer and cefixime are about 0.9 and 1.0, respectively. ]
Resolution: NLT 2.0 between cefixime and cefixime (E)-isomer, System suitability solution
Column efficiency: NLT 4000 theoretical plates, Standard solution. Use the following formula to calculate column efficiency:
Result = 5.545(t/Wh/2)2
Tailing factor: NLT 0.9 and NMT 2.0 for the analyte peak, Standard solution. Use the following formula to calculate tailing factor:
Result = W0.1/2f
Relative standard deviation: NMT 2.0%, Standard solution
Samples: Standard solution and Sample solution
Calculate the percentage of C16H15N5O7S2 in the constituted suspension prepared from the Cefixime for Oral Suspension:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: 90.0%120.0%
• Uniformity of Dosage Units 905 FOR SOLIDS PACKAGED IN SINGLE-UNIT CONTAINERS: Meets the requirements
• Deliverable Volume 698: Meets the requirements
• pH 791: 2.54.5, in the suspension constituted as directed in the labeling
• Packaging and Storage: Preserve in tight containers.
• Labeling: Label it to indicate that the cefixime contained therein is in the trihydrate form.
• USP Reference Standards 11
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2548Pharmacopeial Forum: Volume No. 34(6) Page 1441