Development of a capillary electrophoretic method for the analysis of amino acids containing tablets.
Ketosteril is an enteral medicinal product indicated for prevention and therapy in chronic renal insufficiency in connection with a low protein diet. Tablets of Ketosteril contain five essential amino acids like: Lys, His, Thr, Trp, Tyr and another five amino acids in the form of their hydroxy and keto analogues as calcium salts, that are: alpha-ketoleucine, alpha-ketoisoleucine, alpha-ketovaline, alpha-ketophenylalanine and alpha-hydroxymethionine. The composition of Ketosteril tablets is routinely tested with three LC methods. Capillary electrophoretic method seems to be a good alternative for amino acids and their analogues determination in multicomponent pharmaceuticals because of short analysis time and the possibility to assay all components during a single run without any pretreatment. Electrophoresis was performed in 50 microm I.D. fused-silica capillaries with 65 cm distance to the detector. Capillaries were installed in Waters Quanta 4000 electrophoretic equipment with a positive power supply and on-line UV detection at 214 nm. Separations were done in a buffer containing 40 mM Tris and 160 mM boric acid titrated with NaOH to pH 10. The method developed allows the separation of all investigated analytes with an efficiency of n = 230,000 and 20 min analysis time. The method was applied for determination of all components of Ketosteril in commercial tablets.
Department of Biological Preparations, Drug Institute, Chelmska 30134 Str., 00-725 Warsaw, Poland. m-jaworska@il.waw.pl
Małgorzata
M
Jaworska
Zofia
Z
Szulińska
Małgorzata
M
Wilk
D000596:Amino Acids / Q000032:analysis*; D019075:Electrophoresis, Capillary / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets / Q000737:chemistry*
D000596:Amino Acids; D013607:Tablets