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Development and validation of HPLC method to quantify Zofenopril in tablet

Wafa Ben mabrouk Bouaissi, Najib Ben Hmida


An accurate, simple, reproducible and sensitive liquid chromatographic method was developed and validated for the Zofenopril Calcium determination in tablet. The analyses were performed at room temperature on a reversed-phase Prontosil LC18 Knauer C18 column (250 mm * 4.6 mm grain size of 5 μm). The detection of the dosage form was carried out at 205 nm. The mobile phase was composed of acetonitrile: phosphate buffer (pH 2.5, 0.02 M) (80:20, v/v), and it was eluted isocratically at a 2.0 mL min-1 flow rate. The retention time for Zofenopril was found to be 4.27 min. The method was validated in terms of specificity, linearity, quantification limit, detection limit, accuracy and precision. The response was linear in the range 90 - 210 µg/mL.The correlation coefficients (R2) regression equations are greater than 0.995. The relative standard deviation values for inter-and intra-day precision are less than 2 %. Recoveries ranged between 99.34 and 100.21%. The method was successfully applied for the determination of Zofenopril in the pharmaceutical formulation.

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