Abstract
A reversed phase high-performance liquid chromatographic (RP-HPLC) method was adopted and validated as a stability indicating method for the determination of ramipril (RMP) in presence of its degradation products. The degradation process was performed under acidic, basic, oxidative and thermal conditions, as recommended by the International Conference on Harmonization (ICH)-guidelines. Also, the stability of the tablet form was studied under the storage conditions indicated by the ICH-guidelines (temperature of 40 degrees C and relative humidity of 75%, for 6 months). The cited method was validated according to the guidelines of ICH-Q2B. The method was conducted on Hypersil (TM) ODS C-18 column (150 x 4.6 mm, 5 mu m) as a stationary phase. The mobile phase was optimized to be 0.05 M potassium dihydrogen phosphate buffer (adjusted to pH 5 using orthophosphoric acid): acetonitrile (15: 85, v/v), pumped using an isocratic pump. The method was found to be suitable for the analysis of RMP in bulk and dosage forms.