BRIEFING

 Olmesartan Medoxomil and Hydrochlorothiazide Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The proposal for this drug product which appeared in PF 46(3) has been canceled and is being replaced with a new proposal.

1. The liquid chromatographic procedure in the Assay was validated using the Acquity UPLC HSS T3 brand of column with L1 packing. The typical retention times for hydrochlorothiazide and olmesartan medoxomil are about 1.0 and 2.3 min, respectively.

2. The liquid chromatographic procedure in Dissolution Test 1 was validated using the Acquity UPLC HSS T3 brand of column with L1 packing. The typical retention times for hydrochlorothiazide and olmesartan medoxomil are about 0.6 and 1.9 min, respectively.

3. The liquid chromatographic procedure in Dissolution Test 2 was validated using the ACE CN brand of column with L10 packing. The typical retention times for hydrochlorothiazide and olmesartan medoxomil are about 4.0–5.0 and 5.1–8.0 min, respectively.

4. The liquid chromatographic procedure in the test for Organic Impurities was validated using the Genesis CN brand of column with L10 packing. The typical retention times for hydrochlorothiazide and olmesartan medoxomil are about 7 and 29 min, respectively.

 (SM6: F. Gu)

 Case ID—SUB-2232, SUB-2537