ISSN : 2663-2187

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING CE ASSAY METHOD FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE AND LISINOPRIL IN PHARMACEUTICAL FORMULATIONS

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A. Ramyasree,MD. Abdul Sattar,Ravichandra Sharabu, Narapalli Sirisha , Vithanala Srinivasa Rao
ยป doi: 10.48047/AFJBS.6.72024. 823-839

Abstract

A simple, accurate, precise and sensitive capillary electrophoresis method has been optimized for the separation and stability indicating assay of antihypertensive drugs, amlodipine and lisinopril in the commercial tablet formulations. The separation of both drugs and their degradation products were tested and evaluated under different electrophoretic conditions and best results were obtained using a fused silica capillary with 25mM phosphoric acid buffer (pH 2.45). The detection was performed at a UV wavelength of 214 nm. In this optimized method, 4-Aminopyridine has been used as an internal standard and is stable over stressed conditions used in this experiment. The drugs were subjected to oxidation, hydrolysis, photolysis and heat to apply stress conditions. The proposed CE method is also superior over the reported TLC method in terms of simplicity, cost and resolving the number of degradation products. The method was also validated. This is the first report on an ideal stability indicating CE method that quantifies selectively amlodipine and lisinopril in the presence of degradation products

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