DETERMINATION OF ACETATE IN PHARMACEUTICAL PRODUCTS BY HPLC†
Svjetlana Mihaljica, Jelena Trbojević
Institute of Pharmacy of Serbia, Vojvode Stepe 458, Belgrade, Yugoslavia
Marija Mašković
Institute of Pharmacy of Serbia, Vojvode Stepe 458, Belgrade, Yugoslavia
Abstract
HPLC method, using anion
exchange column and UV/Vis detector, for identification and determination of
acetate in medicinal products is described in this study. SUPELCOSIL SAX1 strong
anion exchange column has ion exchange character. In the ion exchange mode,
different pH and ion strength will influence the retention time of acetate.
Increasing the ionic strength will reduce its retention time. Changing the pH
will control the protonation state of the analyte.
Acetate has been found in
those products as salt L-Lysinacetate. Validation of the method establishes that
its performance characteristics (figures of merits, quality of parameters) are
adequate for the intended use. It entails the evaluation of number of
parameters, such as selectivity, linearity, accuracy, specificity, precision
(repetability and reproducibility), sensitivity, detection and determination
limits and robustness.