%0 Journal Article
%T A Validated Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Aliskiren Hemifumarate and Amlodipine Besylate in Pharmaceutical Dosage Form
%A Chinnalalaiah Runja
%A P. Ravikumar
%A Srinivasa Rao Avanapu
%J Chromatography Research International
%D 2014
%I Hindawi Publishing Corporation
%R 10.1155/2014/628319
%X The present study describes the stability indicating RP-HPLC method for simultaneous estimation of aliskiren hemifumarate and amlodipine besylate in pharmaceutical dosage forms. The proposed RP-HPLC method was developed by using waters 2695 separation module equipped with PDA detector and chromatographic separation was carried on C-8 Inertsil ODS (150 ¡Á 4.6£¿mm, 5£¿¦Ì) column at a flow rate of 1£¿mL/min and the run time is 10£¿min. The mobile phase consisted of phosphate buffer and acetonitrile in the ratio of 40£¿:£¿60%£¿v/v and pH was adjusted to 3 with orthophosphoric acid and eluents were scanned using PDA detector at 237£¿nm. The retention time of aliskiren and amlodipine was found to be 3.98 and 5.14£¿min, respectively. A linearity response was observed in the concentration range of 30¨C225£¿¦Ìg/mL for aliskiren and 2¨C15£¿¦Ìg/mL for amlodipine, respectively. Limit of detection and limit of quantification for aliskiren are 0.161£¿¦Ìg/mL and 0.489£¿¦Ìg/mL and for amlodipine are 0.133£¿¦Ìg/mL and 0.404£¿¦Ìg/mL, respectively. The stability indicating method was developed by subjecting the drugs to stress conditions such as acid and base hydrolysis, oxidation, and photo- and thermal degradation and the degraded products formed were resolved successfully from the samples. 1. Introduction Aliskiren is a novel antihypertensive agent and is the first orally active rennin inhibitor indicated for the treatment of hypertension [1¨C3]. Chemically, aliskiren is (2S, 4S, 5S, 7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy) phenyl]-octanamide [4] (Figure 1(a)). Renin is secreted by the kidney, which cleaves the angiotensinogen to form angiotensin I and is then converted into angiotensin II by angiotensinogen converting enzyme. Aliskiren inhibits the catalytic activity of rennin system and inhibits the generation of angiotensin I and angiotensin II [5¨C7]. Figure 1: (a) Chemical structure of aliskiren. (b) Chemical structure of amlodipine. Amlodipine is a member of 1, 4-dihydropyridine class of calcium antagonist approved for the treatment of heart diseases like hypertension and angina pectoris. It is a long acting calcium channel blocker that inhibits the influx of calcium ions into the vascular smooth muscle and cardiac muscle [8, 9]. Chemically amlodipine is 3-ethyl-5-methyl 2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-1,4-dihydropyridine-6-methyl-3,5-dicarboxylate [10] (Figure 1(b)). Through literature survey reveals that there are few analytical methods such as RP-HPLC [11, 12] and UV methods [13, 14] are reported for
%U http://www.hindawi.com/journals/cri/2014/628319/