BRIEFING

 Sumatriptan and Naproxen Sodium Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.

1. The liquid chromatographic procedure in the Assay is based on analyses performed with the Inertsil Ph-3 brand of column with L11 packing. The typical retention times for sumatriptan and naproxen are about 7 and 17 min, respectively.

2. The liquid chromatographic procedure in the Dissolution test is based on analyses performed with the Zorbax StableBond-Phenyl brand of column with L11 packing. The typical retention times for sumatriptan and naproxen are about 3 and 11 min, respectively.

3. The liquid chromatographic procedure in the Organic Impurities, Procedure 1: Sumatriptan test is based on analyses performed with the ACE C18-PFP brand of column with L1 packing. The typical retention time for sumatriptan is about 12 min.

4. The liquid chromatographic procedure in the Organic Impurities, Procedure 2: Naproxen Sodium test is based on analyses performed with the Kinetex C18 brand of column with L1 packing. The typical retention time for naproxen is about 10 min.

 (SM4: R. Radhakrishnan)

 Case ID—SUB-739