Quality Of Amlodipine Besylate

Objection: use High Performance Liquid Chromatography (hereafter refer to asHPLC, as in Chinese pharmacopoeia in 2005 version two appendices V D) toaccess the related matter and their content;use UV spectrophotometry (as inChinese pharmacopoeia in 2005 version two appendices IV A) to inspect itsdissolve.Methods:HPLC: The octadecyl silicon hydride linkage silica gel column (4.6 *250mm, 5um);the methyl alcohol potassium dihydrogen phosphate solution(65:35);the examination wavelength is 238nm;the speed of flow is 0.8mL/min.UV spectrophotometry: the solvent is hydrochloric acid solution (0.9 -> 1000)500mL;the rotational speed is 75 per minute.Conclusions: in its exclusive experiment, its puncture experiment, and otherrelative material experiment, this matter's various impurities peak and theprominent peak have respective ownership, and also this matter can be very gooddissolved;it conforms to the pharmacopoeia stipulation. This researchsignificantly helps to reduce the quality disparity between domestic product andimported product, to instruct the preparation prescription craft optimization, toimprove and control the quality of this matter.