BRIEFING
Naproxen Sodium and Diphenhydramine Hydrochloride Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.
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The proposed liquid chromatographic procedure in the Assay is based on validation using the X-Bridge BEH C8 brand of column with L7 packing. The typical retention times for naproxen and diphenhydramine are about 3.4 and 11 min, respectively.
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The proposed liquid chromatographic procedure in the Dissolution test is based on validation using the X-Bridge BEH C18 brand of column with L1 packing. The typical retention times for naproxen and diphenhydramine are about 1.8 and 3.2 min, respectively.
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The proposed liquid chromatographic procedure in the Organic Impurities test is based on validation using the X-Bridge BEH C18 brand of column with L1 packing. The typical retention times for naproxen and diphenhydramine are about 9 and 22 min, respectively.
(SM2: S. Parepalli)
Case ID—SUB-1124