Hplc Method Development of Amlodipine by Rp-hplc in Its Bulk Dosage Forms

A new, simple, precise, sensitive, accurate and reproducible Reverse phase HPLC method was developed and validated for the analysis of amlodipine in bulk dosage forms. The separation was conducted by using c-18 RP-HPLC coloumn, which was maintained at ambient temperature. The mobile phase consisting of Phosphate buffer and Acetonitrile (90:10v/v) was delivered at a rate of 1.5 ml/min. The analysis was detected by using UV detector at the wave length of 225nm.The method is validated for its specificity, precision, accuracy, linearity and robustness. The method was found to be linear over the concentration range 10-100 g/ml (r =0.999). The retention time for amlodipine was found to be 3.34min. Limit of quantification of the method is 0.179g/ml and limit of detection is 0.054 g/ml. INTRODUCTION: Amlodipine chemically known as 3ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2chlorophenyl)-6-methyl-1, 4-dihydropyridine-3, 5dicarboxylate . Amlodipine is a long-acting 1,4dihydropyridine calcium channel blocker. That inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Serum calcium concentration is not affected by amlodipine. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. This paper describes a fast, sensitive, rapid and accurate method for developed and validated 2, 3, . The analysis of amlodipine in bulk dosage forms by using Reverse PhaseHigh Performance Liquid Chromatography(RP-HPLC) . The proposed method is optimized and validated as per the International Conference on Harmonization (ICH) guidelines . MATERIALS AND METHODS: Instrumentation: Quaternary isocratic HPLC (Younglin HPLC YL9000 series) with YL 9110 Pump and with autochro 3000 software and UV-Vis detector YL9120, electronic balance (Shimadzu) was used for weighing the sample. Reagents and Chemicals: Amlodipine was obtained from FDC limited Goa and acetonitrile and water employed for the preparation of mobile phases were of HPLC grade (qualigens fine chemicals, Mumbai). All the other chemicals and solvents viz phosphate buffer and acetonitrile are of ambient grade. Correspondence to Author: