Advancing USP compendial methods for fixed dose combinations: A case study of metoprolol tartrate and hydrochlorothiazide tablets.

ABSTRACT: The current United States Pharmacopeia-National Formulary (USP-NF) includes more than 250 monographs of fixed dose combinations (FDCs), and some of them need to be updated due to incompleteness of impurity profiles and obsolescence of analytical methodologies. A case study of metoprolol tartrate and hydrochlorothiazide tablets is presented to summarize challenges encountered during the USP monograph modernization initiative of FDCs and to highlight an "adoption and adaptation" approach employed for method development. To this end, a single stability-indicating HPLC method was developed to separate the two drug substances and eight related compounds with resolution 2.0 or higher between all critical pairs. Chromatographic separations were achieved on a Symmetry column (C₁₈, 100 m

SUBMITTER: Xu Q 

PROVIDER: S-EPMC6460378 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature