BRIEFING

 Saxagliptin and Metformin Hydrochloride Extended-Release 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 procedures used in the Assay, Procedure 1: Saxagliptin, and the Dissolution, Procedure 1: Saxagliptin test were validated using the Sunfire C18 brand of column with L1 packing. The typical retention times for saxagliptin are about 4.4 min for Assay, Procedure 1: Saxagliptin, and 6.5 min for the Dissolution, Procedure 1: Saxagliptin test.

2. The liquid chromatographic procedure used in the Organic Impurities, Procedure 1: Saxagliptin test was validated using the Zorbax Eclipse AAA brand of column with L1 packing. The typical retention time for saxagliptin is about 18 min.

3. The liquid chromatographic procedures used in Assay, Procedure 2: Metformin Hydrochloride and the Organic Impurities, Procedure 2: Metformin Hydrochloride test were validated using the μBondapak C18 brand of column with L1 packing. The typical retention time for metformin is about 7.5 min for Assay, Procedure 2: Metformin Hydrochloride and the Organic Impurities, Procedure 2: Metformin Hydrochloride test.

 (SM3: P. Pabba)

 Case ID—SUB-679