Amlodipin optical analysis via HPLC using lux cellulose column

Abstract

    Amlodipine (AM) consists of two isomers (S)-AM (S) and (R)-AM (R); however, only (S) is active. Currently, there is no separate monograph for (S) in the pharmacopoeia and the optimal method of quantification, separation for (S) and (R). Research was carried out using HPLC on research subjects including 5mg AM tablets; 2.5mg and 5mg (S)-AM tablets; reference agents AM besilate and (S)-AM besilate; chemicals and solvents up to analytical standards and separation columns include lux cellulose-(1, 2, 3 and 4). Procedure: First, survey the column, evaluate the possibility of separation. Next, investigate the mobile phase, select the most suitable mobile phase system. Finally, validate the method (according to ICH). The results show that the lux cellulose-4 column can completely separate the mixture at 237 nm with the acetonitrile-ethanol-diethylamine system at the ratio of 90:10:0.1 (v:v:v). On validation (according to ICH), the method met requirements for specificity, linearity, precision, accuracy, limit of detection, limit of quantification with resolution > 2.5, range of determination 0.1 to 1.0 µg/mL, relative standard deviation < 2 % (n = 6), recovery (98-102) %. Thus, HPLC using lux cellulose-4 column with acetonitrile-ethanol- diethylamine system (90:10:0,1) proves suitable for separating (S) and (R), thus can be a new method for quantification (S) and testing preparations containing AM or (S) on the market