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A validated method for the determination and purity evaluation of benazepril hydrochloride in bulk and in
T Radhakrishna1, D S Rao, K Vyas
1Department of Analytical R&D, Dr. Reddy's Research Foundation, Miyapur, Hyderabad, India.
Abstract:
A gradient liquid chromatographic (LC) method has been developed for the determination and purity evaluation of benazepril hydrochloride in bulk and pharmaceutical dosage forms. The method is simple, rapid and selective. 5-Methyl-2-nitro phenol has been used as internal standard. The method is linear in the range of 50-800 microg. The precision for inter and intra-day assay variation of benazepril hydrochloride is below 1.6% RSD. The accuracy determined as relative mean error (RME) for the intra-day assay is within +/- 2.0%. The method is stability indicating, and is useful in the quality control of bulk manufacturing and also in pharmaceutical formulations.