Naproxen Tablets
Action and use
Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.
Definition
Naproxen Tablets contain Naproxen.
Content of naproxen, C14H14O3
95.0 to 105.0% of the stated amount.
Identification
Tests
Dissolution
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
Calculate the total content of naproxen, C14H14O3, in the medium using the declared content of C14H14O3 in naproxen BPCRS.
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
3 volumes of glacial acetic acid, 9 volumes of tetrahydrofuran and 90 volumes of toluene.
Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.5%).
Assay
Weigh and powder 20 tablets. Shake a quantity of the powder containing 50 mg of Naproxen with 70 mL of methanol for 30 minutes, add sufficient methanol to produce 100 mL and filter. Dilute 10 mL of the filtrate to 50 mL with methanol and measure the absorbance at the maximum at 331 nm, Appendix II B. Calculate the content of C14H14O3 from the absorbance obtained by repeating the operation using a 0.01% w/v solution of naproxen BPCRS in methanol and using the declared content of C14H14O3 in naproxen BPCRS.
Storage
Naproxen Tablets should be protected from light.