BRIEFING
Bosentan 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 in the Assay is based on validation performed with the Zorbax SB-Phenyl brand of column with L11 packing. The typical retention time for bosentan is about 13 min.
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The liquid chromatographic procedure in the test for Dissolution is based on validation performed with the Symmetry C8 brand of column with L7 packing. The typical retention time for bosentan is about 4.5 min.
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The liquid chromatographic procedure in the test for Organic Impurities is based on validation performed with the Zorbax Eclipse XDB C18 brand of column with L1 packing. The typical retention time for bosentan is about 18 min.
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The gas chromatographic procedure in the test for Limit of Ethylene Glycol is based on validation performed with the DB-WAX brand of column with stationary phase G16. The typical retention time for ethylene glycol is about 12 min.
(SM5: M. Koleck)
Correspondence Number—C217433