Oxcarbazepine
(ox'' kar baz' e peen).
C15H12N2O2 252.27 5H-Dibenz[b,f]azepine-5-carboxamide, 10,11-dihydro-10-oxo-; 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide [28721-07-5]. DEFINITION
Oxcarbazepine contains NLT 98.0% and NMT 102.0% of C15H12N2O2, calculated on the anhydrous basis.
IDENTIFICATION
• A. Infrared Absorption 197K
[NoteIf the spectrum obtained shows differences, dissolve the substance to be examined in chloroform, and evaporate to dryness. Compare the spectrum of the residue to that of a similarly prepared USP Oxcarbazepine RS. ]
• B.
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
Buffer:
6.8 g/L of monobasic potassium phosphate in water. For each L prepared add 2 mL of triethlyamine and mix. Adjust with phosphoric acid to a pH of 6.0 ± 0.1.
Mobile phase:
Methanol, acetonitrile, and Buffer (11:8:31)
Standard solution:
0.1 mg/mL of USP Oxcarbazepine RS in Mobile phase
Sample solution:
0.1 mg/mL of Oxcarbazepine in Mobile phase
Chromatographic system
Mode:
LC
Detector:
UV 215 nm
Column:
4.6-mm × 25-cm; 5-µm packing L1
Column temperature:
50
Flow rate:
1.5 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements:
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C15H12N2O2 in the portion of Oxcarbazepine taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria:
98.0%102.0% on the anhydrous basis
IMPURITIES
SPECIFIC TESTS
• Water Determination, Method Ia 921:
NMT 0.5%
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers. Store at controlled room temperature.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4158
Pharmacopeial Forum: Volume No. 34(5) Page 1177
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