title: A comparison of two methods to determine the solubility of compounds in aerosol propellants.
abstract: A new on-line reverse phase HPLC method for determining the solubility of compounds in propellant based metered dose inhaler (MDI) formulations was compared with a conventional method. The new method employs a direct injection from a MDI vial into the needle injector port of a manual injector. To evaluate the two methods, beclomethasone dipropionate (BDP), 5,5-diphenyl hydantoin and 3,3'-diindolylmethane, were used as model compounds in propellant HFA-134a. Comparison was performed by analyzing known and unknown concentrations of BDP in various combinations of HFA-134a and ethanol. In addition, the solubility of 5,5-diphenyl hydantoin and 3,3'-diindolylmethane were determined in HFA-134a using both the new and the conventional methods. The two methods were found to be in good agreement with each other, with the new direct injection technique offering enhanced precision and accuracy along with considerable reduction in analysis time.
authors.affiliation: Inhalation Formulation, Cardinal Health, P.O. Box 13341, Research Triangle Park, NC 27709, USA.
authors.forename: Abhishek
authors.initials: A
authors.lastname: Gupta
authors.forename: Paul B
authors.initials: PB
authors.lastname: Myrdal
mesh_terms: D000335:Aerosol Propellants / Q000032:analysis* / Q000737:chemistry; D001507:Beclomethasone / Q000032:analysis; D004338:Drug Combinations; D007211:Indoles / Q000737:chemistry; D036501:Metered Dose Inhalers; D010672:Phenytoin / Q000032:analysis; D012995:Solubility; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods* / Q000639:trends*
chemical_list: D000335:Aerosol Propellants; D004338:Drug Combinations; D007211:Indoles; D010672:Phenytoin; D001507:Beclomethasone; C016392:3,3'-diindolylmethane