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Stability of Mixtures Formulated from Warfarin Tablets or Powder
Author(s) -
Sharley Nicholas A,
Yu Annie MC,
Williams Desmond B
Publication year - 2007
Publication title -
journal of pharmacy practice and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.222
H-Index - 22
eISSN - 2055-2335
pISSN - 1445-937X
DOI - 10.1002/j.2055-2335.2007.tb00026.x
Subject(s) - warfarin , warfarin sodium , chromatography , preservative , high performance liquid chromatography , hydrate , medicine , chemistry , organic chemistry , cardiology , atrial fibrillation
Background Although warfarin is a commonly prescribed oral anticoagulant, published data on the stability of mixtures prepared from warfarin tablets are limited. Aim To investigate the stability of mixtures formulated using Coumadin tablets, Marevan tablets or warfarin sodium clathrate. Method A stability indicating high performance liquid chromatography (HPLC) method was developed to determine the concentration of warfarin. Warfarin sodium clathrate was forcibly degraded and injected into the HPLC system to ascertain lack of interference from degradation product peaks from the warfarin peak. Warfarin mixtures (1 mg/mL) were prepared in triplicate from Coumadin tablets, Marevan tablets and warfarin sodium clathrate using compound hydroxybenzoate solution APF as a preservative. A four‐level calibration was used. On each study day each sample was injected into the HPLC system in duplicate together with quality control standards and blanks. Warfarin concentrations were calculated from the linear regression equation derived from the calibration curve. Results The method was stability indicating as the degradation peaks did not interfere with the principal peak and UV spectral confirmation was used to identify the warfarin peak. All mixtures retained at least 98% of their original concentration over the 28‐day study period. Conclusion Warfarin mixtures can be formulated by either suspending crushed tablets or preparing a solution from warfarin sodium clathrate. Compound hydroxybenzoate solution APF can be used as the preservative. A 28‐day shelf‐life can be assigned to the products.