title: Validation of an analytical method for quality control of residual solvents (n-hexane and acetone) in D-002: new active ingredient from beeswax.
abstract: D-002 is a new natural product consisting of a mixture of aliphatic fatty alcohols, which shows antioxidant and anti-ulcer effects in experimental models. A new validated methodology for determining simultaneously residual n-hexane and acetone in D-002 using the headspace gas chromatography (HS/GC) is described. The very poor solubility of D-002 in most solvents did necessary sample preparations in solid state. Limit test conditions allowed a detection of residual n-hexane and acetone more sensitively than that recommended for such purposes in the general method of the European Pharmacopoeia. Validation assays, applied to both D-002 residual solvents, proved: suitable sensitivity; very high linearity (correlation coefficients > or =0.999, R.S.D. of slopes < or =0.8% and R.S.D. of response factors < or =5% and no biases) and accuracy (average recoveries between 94.7 and 100.1%); and precision was < or =2.1%. The method was found suitable for quality control and stability studies of this new product.
authors.affiliation: National Center for Scientific Research, Cubanacán, Playa, PO Box 6414, Havana City, Cuba. ernesto.mendez@cnic.edu.cu
authors.forename: Ernesto Méndez
authors.initials: EM
authors.lastname: Antolín
authors.forename: Yaisme Balcinde
authors.initials: YB
authors.lastname: Quiñónez
authors.forename: Víctor González
authors.initials: VG
authors.lastname: Canavaciolo
authors.forename: Esperanza Rodríguez
authors.initials: ER
authors.lastname: Cruz
mesh_terms: D000096:Acetone / Q000032:analysis*; D002849:Chromatography, Gas; D005233:Fatty Alcohols / Q000032:analysis / Q000592:standards*; D006586:Hexanes / Q000032:analysis*; D011786:Quality Control; D012997:Solvents / Q000032:analysis*
chemical_list: C104511:D 002; D005233:Fatty Alcohols; D006586:Hexanes; D012997:Solvents; D000096:Acetone; C026385:n-hexane