BRIEFING

 Linagliptin and Metformin Hydrochloride 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 used in the Assay for Linagliptin was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for linagliptin is about 6 min.

2. The liquid chromatographic procedure used in the Assay for Metformin Hydrochloride was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for metformin is about 7 min.

3. The test for Dissolution for Linagliptin was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for linagliptin is about 5 min.

4. The liquid chromatographic procedure used in the test for Organic Impurities: Linagliptin was validated using the Inertsil ODS-3 brand of column with L1 packing. The typical retention time for linagliptin is about 28 min.

5. The liquid chromatographic procedure used in the test for Organic Impurities: Metformin Hydrochloride was validated using the Partisil SCX brand of column with L9 packing. The typical retention time for metformin is about 22 min.

 (SM3: R. Fales)

 Case ID—SUB-1799