title: Validation of a gas chromatographic method for determining fatty acids that compose D003 in 10 mg film-coated tablets.
abstract: D003 is a new product composed of a mixture of aliphatic fatty acids (C(24:0) to C(36:0)), which shows antiplatelet, antithrombotic, antioxidant, and cholesterol-lowering effects in experimental models and human beings. A gas chromatographic method using a DB-5 wide-bore column and 1-nonadecanoic acid as internal standard was developed and validated in order to determine D003 in 10 mg film-coated tablets. The acids were analysed as methyl esters derivatives, prepared using 5% aqueous HCl-methanol. Developed method was specific for the active principle, even when samples were subjected to stress conditions. Good linearity (correlation coefficient > 0.99) and accuracy (total average recovery = 100.29%) were proven over a range 50-150% of the nominal concentration. Within-day and intermediate precisions at the nominal dose (100%) were < 1.5%. Robustness was examined through an intralaboratory study, quantification and resolution were only affected by the injection volume increase and no other of the 7 operational changes evaluated affected the results. The method was suitable for quality control and stability studies of these tablets.
authors.affiliation: Center of Natural Products, National Center for Scientific Research, Cubanacán, Playa, PO Box 6414, Havana City, Cuba. clinica@enet.cu
authors.forename: Ernesto Méndez
authors.initials: EM
authors.lastname: Antolín
authors.forename: David
authors.initials: D
authors.lastname: Marrero Delange
authors.forename: Víctor
authors.initials: V
authors.lastname: González Canavaciolo
authors.forename: Yanet
authors.initials: Y
authors.lastname: Tejeda Díaz
authors.forename: Roxana
authors.initials: R
authors.lastname: Sierra Pérez
authors.forename: Miriam
authors.initials: M
authors.lastname: Cora Medina
mesh_terms: D000818:Animals; D000924:Anticholesteremic Agents / Q000032:analysis* / Q000737:chemistry; D002849:Chromatography, Gas / Q000379:methods* / Q000592:standards; D004355:Drug Stability; D005227:Fatty Acids / Q000032:analysis* / Q000737:chemistry; D006801:Humans; D011786:Quality Control; D015203:Reproducibility of Results; D013608:Tablets, Enteric-Coated / Q000032:analysis* / Q000737:chemistry
chemical_list: D000924:Anticholesteremic Agents; C478823:D003 preparation; D005227:Fatty Acids; D013608:Tablets, Enteric-Coated