Akademik Veri Yönetim Sistemi
CHROMATOGRAPHIA, cilt.79, sa.17-18, ss.1143-1151, 2016 (SCI-Expanded)
In the proposed work, the simultaneous analysis of amlodipine-rosuvastatin and amlodipine-atorvastatin in their dosage forms was achieved. Simultaneous dissolution profiles of the amlodipine-rosuvastatin and amlodipine-atorvastatin tablets are realized using Apparatus II with a simple, accurate and precise RP-LC method. The mobile phase consisting of 0.2 % H3PO4 and pH 5:methanol:acetonitrile (46:27:27) was used. The samples of 10 A mu L were injected onto a Zorbax SB C18 (100 mm, 4.6 mm, 3.5 A mu m particle size) column with 1.2 A mu L min(-1) flow rate. The samples were detected at 236 nm. By plotting peak area ratios vs. concentration, the linearity for amlodipine-rosuvastatin and amlodipine-atorvastatin was determined. With the developed RP-LC method, AML, ROS and ATOR were detected within the range of 0.25-10, 0.5-10 and 0.25-25 A mu g mL(-1), respectively. LOD and LOQ values were also calculated as 0.028, 0.058, 0.021 and 0.095 A mu g mL(-1), 0.195 A mu g mL(-1), 0.070 A mu g mL(-1) for AML, ROS and ATOR, respectively. System suitability tests parameters, such as capacity factor, selectivity to previous peak, selectivity to next peak, resolution to previous peak, resolution to next peak, tailing factor, theoretical number of plates, were performed and found coherent with the ICH guideline parameters. The proposed method has been extensively validated in terms of recovery, and recovery results were between 99 and 101 %. For proving the precision, between-day and within-day repeatability results of the method were proposed. The method can be used for the simultaneous determination of amlodipine-rosuvastatin and amlodipine-atorvastatin.