DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR DETERMINATION OF AMLODIPINE AND BENAZEPRIL IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC
Thigulla Shivani*, G. Kalyani, Vijaya Kuchana and Pasupuleti Sunitha
ABSTRACT
A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Amlodipine and Benazepril, in its pure form as well as in capsule dosage form. Chromatography was carried out on an Altima C18 (4.6 x 150 mm, 5μm) column using a mixture of Methanol: TEA Buffer pH 4.5: Acetonitrile (50:25:25) as the mobile phase at a flow rate of 1.0 mL/min, the detection was carried out at 225 nm. The retention time of the Amlodipine and Benazepril was 2.102, 3.537 ±0.02 min respectively. The method produce linear responses in the concentration range of 5-25μg/ml of Amlodipine and 20-100 μg/ml of Benazepril. The method precision for the determination of assay was below 2.0 %RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.
Keywords: Amlodipine, Benazepril, RP-HPLC, Validation.
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