FOSINOPRIL–SODIUM AND ITS DEGRADATION PRODUCT ANALYSIS IN MONOPRIL^® TABLETS^†

Biljana Jančić,^a Darko Ivanović,^a Mirjana Medenica,^b and Andjelija Malenović^a

 

^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

 

Abstract

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 Monopril^Ò tablets.