METHOD FOR CHROMATOGRAPHIC SEPARATION OF COMBINED SOLID DOSAGE FORM CONTAINING AMLODIPINE AND VALSARTAN

摘要

FIELD: measurement technology.;SUBSTANCE: invention relates to chromatography and can be used for analysis and study of medicinal preparations based on valsartan and amlodipine having similar chemical structure and sorption properties. Method for chromatographic separation of solid combined dosage form containing amlodipine and valsartan using the reverse phase HPLC method and a UV spectrophotometric detector. Analysis is carried out at chromatographic Luna C18 (2) column with the size of 150×4.6 mm filled with octadecylsilyl silica gel with the particle size of 5 mcm in the gradient mode at which separation is accompanied by sorption of components of the dosage form at Luna C18 column (2) 150×4.6 mm, 5 mcm. Triethylamine that is ion-pair addition to the mobile phase in amount of 1 % is used as an organic modifier, and methanol and a mixture of mobile phases A and B are used as a solvent for the sample. Thermostatting temperature of the column is 30 °C, detection is performed at wave length 237 nm, mobile phase flow is 1 ml/min.;EFFECT: technical result includes obtaining sufficient resolution between the peaks of substances and high number of theoretical plates for both components during a short period of chromatography, that enables to perform the correct quantitative calculation of the data of the active substances in the analyzed sample.;1 cl, 2 dwg