title: Liquid chromatographic methods for the determination of albuterol (salbutamol), albuterol sulphate and related compounds in drug raw materials, tablets and inhalers.
abstract: Liquid chromatographic methods for the determination of albuterol (salbutamol), albuterol sulphate and related compounds in drug raw materials, tablets and inhalers are described. The methods resolve five known related compounds from the drug and, in the case of inhalers, several compounds not related to the drug. Two of these were identified as 2,6-di-t-butyl-4-methylphenol, a common antioxidant, and 2,2'-methylene bis(6-t-butyl-4-methylphenol). Related compounds are detectable at levels of about 0.03%. Eleven albuterol and 12 albuterol sulphate raw materials and eight tablet formulations were found to contain related compounds ranging from 0.03 to 0.54%, 0.09 to 0.50% and 0.32 to 0.95%, respectively. Non-drug compounds in three inhaler samples ranged from 4.6 to 12% of the drug delivered through the valve. Some of the non-drug compounds may be excipients.
authors.affiliation: Bureau of Drug Research, Health Protection Branch, Ottawa, Ontario, Canada.
authors.forename: N
authors.initials: N
authors.lastname: Beaulieu
authors.forename: T D
authors.initials: TD
authors.lastname: Cyr
authors.forename: E G
authors.initials: EG
authors.lastname: Lovering
mesh_terms: D000420:Albuterol / Q000031:analogs & derivatives / Q000032:analysis*; D002853:Chromatography, Liquid / Q000379:methods*; D004340:Drug Contamination / Q000517:prevention & control; D009330:Nebulizers and Vaporizers; D013607:Tablets
chemical_list: D013607:Tablets; D000420:Albuterol