Development of a dissolution method to compare tablet formulations containing valsartan/amlodipine

Abstract

Dissolution profiles were developed in three different pH media for the evaluation of valsartan/amlodipine (VS/AM) release from tablets. The selection of the most appropriate dissolution method was based on the calculated similarity (f2) and dissimilarity (f1) values. A new HPLC method was developed to quantify VS/AM in tablets. The method was validated in accordance with international guidelines and showed acceptable linearity, accuracy, precision, and selectivity. The system suitability results are within the acceptance criteria. The dissolution method (pH 6.8 phosphate buffer) was selected because it showed the highest f2 and the lowest f1 values for VS and AM among the other tested dissolution media. This method could be used for in vitro quality control and for performing in vitro–in vivo correlation (IVIVC) during the development of new generic tablets.