Validation of a gas chromatographic method for determining fatty acids that compose D003 in 10 mg film-coated tablets

Il Farmaco
Ernesto Méndez AntolínMiriam Cora Medina

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.

References

Mar 18, 2003·Journal of Medicinal Food·Rafael GámezHaydee García
Mar 20, 2003·Journal of Pharmaceutical and Biomedical Analysis·Ernesto Méndez AntolínAbilio Laguna Granja

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Citations

Nov 23, 2007·Journal of Pharmaceutical and Biomedical Analysis·Ernesto Méndez AntolínVíctor González Canavaciolo
Oct 4, 2007·The Journal of Pharmacy and Pharmacology·Miriam NoaNilda Mendoza
Feb 16, 2019·Pharmacoepidemiology and Drug Safety·Kristina StarI Ralph Edwards
Apr 2, 2010·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Christopher A Fausel
Mar 15, 2019·HIV Medicine·Dr Yvonne GilleeceMs Alison Wright

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