Dihydroquinidine contamination of quinidine raw materials and dosage forms: rapid estimation by high-performance liquid chromatography.
Dihydroquinidine is a commonly encountered contaminant in quinidine raw materials. The USP allows 0-20% dihydroquinidine in quinidine products, but the assays used to quantitate dihydroquinidine have been lengthy or have required sophisticated equipment. The present method separates dihydroquinidine from quinidine and provides rapid, precise quantitation of both dihydroquinidine and quinidine. The clinical importance of dihydroquinidine contamination of quinidine dosage forms remains unanswered.
D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D008722:Methods; D011802:Quinidine / Q000031:analogs & derivatives* / Q000032:analysis; D013607:Tablets / Q000032:analysis
D013607:Tablets; D011802:Quinidine