UV spectrophotometric test for analysis of antihypertensive drug combinations containing amlodipine

Abstract

The present study provides rapid test for the identity and quantification of Amlodipine besylate as monoproduct and in double and triple antihypertensive drug combinations. Test represents direct analysis - drug mixtures are analyzed in solution without prior separation using UV-VIS spectrophotometry. The spectral characteristics of the complex spectrum are used for authentication, counterfeiting, identification and assay. Basic spectral characteristics are determined and analytical parameters of the validation process are investigated. The method uses 4 types of calculations for normal and derivative spectrophotometry at different analytical zones and fixed wavelengths in the range 190 - 500 nm. For double mixtures Amlodipine / Valsartan, the best results are obtained by determining at the 1st derivative of the function, the 2nd polynomial level, the presence of 3 smoothing points, the analytical range is 190 - 400 nm, and the fixed lengths of the waves - 266 and 360 nm. For triple mixtures containing Amlodipine / Valsartan / Hydrochlorothiazide, the best results are obtained with IVth calculation type for Amlodipine and Valsartan and Ist, IIIrd and IVth for Hydrochlorothiazide. The developed method was compared with available in European Pharmacopoeia and US Pharmacopoeia methods for assay of Amlodipine substance and tablets respectively. The results show comparability and meet the pharmacopoeia criteria.