FOSINOPRIL–SODIUM AND ITS DEGRADATION PRODUCT ANALYSIS IN MONOPRIL® TABLETS†
Biljana Jančić,a Darko Ivanović,a Mirjana Medenica,b and Andjelija Malenovića
a Institute of Drug Analysis, Faculty of Pharmacy, Vojvode Stepe 450, 11000 Belgrade, Yugoslavia
b Institute of Physical Chemistry, Faculty of Pharmacy, Vojvode Stepe 450, 11000 Belgrade, Yugoslavia
The reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed for the simultaneous determination of fosinopril–sodium and its degradation product in Monopril® tablets. The chromatographic system Hewlett Packard 1100 consisted of a HP 1100 pump, HP 1100 UV-VIS detector and HP ChemStation integrator. Separations were performed on the X Terra™ 150 mm x 4.6 mm, 5 mm particle column at 45 °C. The samples were introduced through a Rheodyne injector valve with a 20 mL sample loop. Methanol-water (75 : 25 v/v) was used as a mobile phase, with flow rate 1 mL/min. pH was adjusted to 3.1 with ortophosphoric acid. UV detection was performed at 220 nm. Propylparaben was used as an internal standard. The results obtained showed a good agreement with the declared contents. Recovery values for fosinopril–sodium were from 101.6% to 102.9%. Content of degradation product SQ 27519 was lower than 5%. The proposed method is rapid, accurate, selective and because of its sensitivity and reproducibility, it may be used for the quantitative analysis of fosinopril–sodium and its degradation product in MonoprilÒ tablets.