A validated method for the determination and purity evaluation of benazepril hydrochloride in bulk and in pharmaceutical dosage forms by liquid chromatography.
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.
Radhakrishna
T
T
Department of Analytical R&D, Dr. Reddy's Research Foundation, Miyapur, Hyderabad, India.
Rao
D S
DS
Vyas
K
K
Reddy
G O
GO
D000806:Angiotensin-Converting Enzyme Inhibitors / Q000737:chemistry / Q000302:isolation & purification; D001552:Benzazepines / Q000737:chemistry / Q000302:isolation & purification*; D002853:Chromatography, Liquid / Q000379:methods*; D004340:Drug Contamination; D004355:Drug Stability; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D013607:Tablets / Q000737:chemistry
D000806:Angiotensin-Converting Enzyme Inhibitors; D001552:Benzazepines; D013607:Tablets; C044946:benazepril