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A New Simultaneous HPLC Analytical Method for Quantification of Benazepril Hydrochloride and its Related Impurities in Bulk Drug Product
A simple and inexpensive method was developed with high performance liquid chromatography with PDA detection for determination of benazepril hydrochloride and its related impurities. The chromatographic separations were achieved on (250×4.6 mm), 5.0 μm make: Symmetry Shield column employing 0.02M tetrabuthylammonium hydroxide + 0.05 % v/v acetic acid : methanol in the ratio of 50:50 (v/v) as mobile phase with isocratic at flow rate 1.0mL/min was chosen. All impurities were eluted within 30 minutes. The column temperature was maintained at 25°C and a detector wavelength of 240 nm was employed. The method was successfully validated by establishing System Suitability, Specificity, Linearity, Precision, Accuracy, Limit of detection and Limit of quantification.
HPLC, Method Validation, Related Impurities, Benazepril Hydrochloride, LOQ, LOD.
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