Development and validation of a reversed-phase liquid chromatographic method for analysis of aspirin and warfarin in a combination tablet formulation.
A stability-indicating liquid chromatographic method for the simultaneous analysis of aspirin and warfarin in warfarin sodium/aspirin combination (DuP 647) tablets has been developed and validated. This paper presents linearity, accuracy, precision, robustness, recovery, limits of detection and quantitation, and cross-validation data. The method has been shown to be specific and stability-indicating, and to give results comparable to existing methods for the individual components. Solution stability has been optimized for routine analysis.
Montgomery
E R
ER
DuPont Merck Pharmaceutical Company, Experimental Station, Wilmington, DE 19880-0353, USA.
Taylor
S
S
Segretario
J
J
Engler
E
E
Sebastian
D
D
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000032:analysis*; D000925:Anticoagulants / Q000032:analysis*; D001241:Aspirin / Q000031:analogs & derivatives / Q000032:analysis*; D002853:Chromatography, Liquid / Q000379:methods*; D004338:Drug Combinations; D004355:Drug Stability; D015203:Reproducibility of Results; D013329:Structure-Activity Relationship; D014859:Warfarin / Q000031:analogs & derivatives / Q000032:analysis*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000925:Anticoagulants; D004338:Drug Combinations; D014859:Warfarin; D001241:Aspirin