Stability Study of Amlodipine Besylate 5mg in Different Test Conditions

Abstract

This research aimed to study the stability of amlodipine besylate (5mg) tablet under different condition. According to united state pharmacopeia (USP monograph). The melting point of amlodipine besylate was found 200C and agreed with results melting point found in the literature. Whereas, the characteristic bond of amlodipine besylate was showed clearly by IR spectroscopy absorption. The assay of active ingredient of (amlodipine besylate) was carried out using HPLC with (Column: 3.9mm* 150mm 5µm packing L1) and (Acetonitrile, methanol, buffer (15:35:50)) was used as a mobile phase in different conditions (ongoing and accelerated). The results were found in ongoing between (108.17% to 103.76%). and accelerated results between (107.32% to 102.51%). The finding of assay in the range of acceptance value (90 -110 %). In addition, other physical test (hardness, Diameter, friability, thickness and disintegration) was measured and results was pass. Therefore, microbiological tests in ongoing and accelerated condition the results were pass. The results of analysis) chemical, physical, microbial) in ongoing and accelerated condition were found in the acceptance limit. That main drug is stable in those conditions.