METHOD COMBINED chromatographic separation of a solid dosage form containing amlodipine and valsartan

摘要

A method of chromatographic separation of a solid combined dosage form containing amlodipine and valsartan, by reverse phase HPLC using UV spectrophotometric detector, characterized in that the separation occurs sorption components of the dosage form (amlodipine and valsartan) column filled with octadecylsilyl siligagelem from water-atsetanitrilno -metanolnyh solutions, analysis is carried out on a chromatographic column of 150 × 4,6 mm, filled with sorbent Luna C18 (2) with dimensions particles of 5 microns, using a mobile phase comprising an organic modifier triethylamine (ionparnaya additive) in an amount of 1%, as the solvent of the sample using methanol and a mixture of mobile phases A and B, thermostatic column temperature is 30 ° C, detektrirovanie performed at a wavelength 237 nm and a gradient mode of chromatography, the retention time of amlodipine is 10 minutes, retention time of valsartan is 15 minutes, the efficiency of the chromatographic column, calculated from the peaks amlodipi on and valsartan is at least 2000 theoretical plates, the relative standard deviations for valsartan and amlodipine peak areas is not more than 2.0%, the asymmetry factors valsartan and amlodipine peaks is not more than 2.0.