Table of Contents
Chromatography Research International
Volume 2014 (2014), Article ID 628319, 7 pages
http://dx.doi.org/10.1155/2014/628319
Research Article

A Validated Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Aliskiren Hemifumarate and Amlodipine Besylate in Pharmaceutical Dosage Form

1Department of Pharmaceutical Chemistry, Joginpally B.R Pharmacy College, Moinabad, Ranga Reddy District, Telangana, India
2Aizant Drug Research Solutions, Hyderabad, Telangana, India
3Department of Pharmacology, Bhaskar Pharmacy College, Moinabad, Ranga Reddy District, Telangana, India

Received 13 August 2014; Revised 13 November 2014; Accepted 14 November 2014; Published 7 December 2014

Academic Editor: Kanji Miyabe

Copyright © 2014 Chinnalalaiah Runja et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

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 × 4.6 mm, 5 µ) 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 30–225 µg/mL for aliskiren and 2–15 µg/mL for amlodipine, respectively. Limit of detection and limit of quantification for aliskiren are 0.161 µg/mL and 0.489 µg/mL and for amlodipine are 0.133 µg/mL and 0.404 µg/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.