Application of 1H-nuclear magnetic resonance spectroscopic method for quinidine to simultaneous determination of quinidine and dihydroquinidine in quinidine sulfate tablets.
Based on the structural differences between quinidine and dihydroquinidine, a 1H-nuclear magnetic resonance spectroscopic method previously reported for quinidine drug substance was modified and shown to be applicable to the quantitative determination of both compounds in quinidine sulfate tablets. Deuterated chloroform was used as the solvent and hexamethylcyclotrisiloxane served as an internal standard. The average recovery and standard deviation of quinidine sulfate (calculated as the sum of quinidine sulfate plus dihydroquinidine sulfate) from synthetic formulations was 98.94 +/- 0.43% (n = 10). Five lots of 200 mg tablets of quinidine sulfate from one commercial source were found to contain from 92.9 to 95.8% quinidine sulfate, and from 1.1 to 7.0% dihydroquinidine sulfate.
Hanna
G M
GM
Food and Drug Administration, New York Regional Laboratory, Brooklyn 11232.
Lau-Cam
C A
CA
D009682:Magnetic Resonance Spectroscopy; D011802:Quinidine / Q000031:analogs & derivatives* / Q000032:analysis*; D013607:Tablets
D013607:Tablets; C014486:hydroquinidine; D011802:Quinidine