Abstract

RP-HPLC HYDROLYTIC STABILITY STUDY OF CANDESARTAN CILEXETIL

Dhia Eldin Elhag*, Martin Nasser Edward Riad and Shimaa Abdelrahman Ahmed

Abstract

In this study the rate and order of hydrolytic degradation of candesartan cilexetil drug standard under both basic and acidic conditions at room temperature were investigated. The obtained samples were then analyzed by using RP-HPLC. The column used was Shim-pack 15x4.6mm i.d, particle size 4.6 μm. The mobile phase was acetonitrile: formic acid (80:20 v/v) in isocratic elution mode. UV detection was performed 254 nm. Base degradation experiments indicated a prominent degradation peak. Moreover, the drug was found to follow first-order degradation kinetics with a rate constant k1 0.111 min-1 and a half-life (t1/2) and shelf-life (t90) 62.4 minutes and 9.45 minutes, respectively. Acid treatment of the drug showed that degradation took place that follows zero-order kinetics with rate constant k0 value of 0.0229μg/ml. min, t1/2 and t90 of 21 hours and 4 hours 16 minutes, respectively. The results of hydrolytic degradation showed that the prodrug is more sensitive to basic than acidic conditions.

Keywords: Candesartan, stability, degradation, RP_HPLC.