BRIEFING
Linagliptin 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 liquid chromatographic procedure used in the Assay was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for linagliptin is about 6 min.
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The liquid chromatographic procedure used in the test for Dissolution was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for linagliptin is about 4 min.
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The liquid chromatographic procedure used in the test for Organic Impurities was validated using the Inertsil ODS-3 brand of column with L1 packing. The typical retention time for linagliptin is about 27 min.
(SM3: R. Fales)
Case ID—SUB-1796, SUB-1798