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.