The objective of the current study is to develop and validate a reverse-phase HPLC according to the recommendations of International Conference On Harmonization (ICH) for the determination of Zofenopril. The effects of flow, pH, percentage of organic solvent and column temperature on the retention time of Zofenopril are studied by HPLC / DAD. Chromatographic separation was performed on a column of type Prontosil LC18 Knauer (250 mm * 4.6 mm grain size of 5 μm) at 25°C using a diode array detector (DAD) at 205 nm and a mobile phase was composed of acetonitrile-phosphate buffer 10 mM at pH 2.5 (80:20, v/v) delivered at flow 2 mL min-1. The method is linear in a concentration range from 90 to 210 μg mL-1. The correlation coefficients (R2) regression equations are greater than 0.995. The precision of the method is demonstrated by the values of coefficients of variance are less than 2%. No interference from any components of dosage forms or degradation products were observed. The results of the validation, the proposed method is simple, specific, linear, precise, accurate and could be applied to the analysis of commercial tablets « Zofénil » with an excellent recovery.
W. Bouaissi, M. Abidi, N. Ben Hamida
Zofenopril, HPLC/DAD, Validation