GC determination of long chain fatty acids that compose D003 in 5-mg film-coated tablets.
D003 is a new product which consists of a mixture of aliphatic fatty acids (C(24:0)-C(36:0)), that shows antiplatelet, antithrombotic and cholesterol-lowering effects in experimental models. A gas chromatographic (GC) 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 5 mg film-coated tablets. The acids were analyzed 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=99.60%) were proven over a range 38-150% of the nominal concentration. Within-day and intermediate precisions at the nominal dose (100%) were <1.5%. The method was suitable for quality control and stability studies of these tablets.
Méndez Antolín
Ernesto
E
National Center for Scientific Research, Center of Natural Products, PO Box 6414, Cubanacán, Playa, Havana City, Cuba.
Marrero Delange
David
D
González Canavaciolo
Víctor
V
Laguna Granja
Abilio
A
D002849:Chromatography, Gas / Q000379:methods*; D005227:Fatty Acids / Q000032:analysis*; D013608:Tablets, Enteric-Coated / Q000032:analysis*
D005227:Fatty Acids; D013608:Tablets, Enteric-Coated