Next Article in Journal
Development and Validation of a Precise, Single HPLC Method for the Determination of Tolperisone Impurities in API and Pharmaceutical Dosage Forms
Previous Article in Journal
Stress Degradation Behavior of Atorvastatin Calcium and Development of a Suitable Stability-Indicating LC Method for the Determination of Atorvastatin, its Related Impurities, and its Degradation Products
Article Menu

Article Versions

Export Article

Open AccessArticle
Sci. Pharm. 2013, 81(1), 115-122; doi:10.3797/scipharm.1209-15

Method Development and Validation of a Stability-Indicating RP-HPLC Method for the Quantitative Analysis of Dronedarone Hydrochloride in Pharmaceutical Tablets

1
Department of Chemistry, Saurashtra University, Rajkot-360 005, Gujarat, India
2
Arts Commerce and Science College, Borsad, Anand, Gujarat, India
*
Author to whom correspondence should be addressed.
Received: 18 September 2012 / Accepted: 5 November 2012 / Published: 5 November 2012
Download PDF [177 KB, uploaded 27 September 2016]

Abstract

A simple, precise, and accurate HPLC method has been developed and validated for the quantitative analysis of Dronedarone Hydrochloride in tablet form. An isocratic separation was achieved using a Waters Symmetry C8 (100 x 4.6 mm), 5 μm particle size column with a flow rate of 1 ml/min and UV detector at 290 nm. The mobile phase consisted of buffer: methanol (40:60 v/v) (buffer: 50 mM KH2PO4 + 1 ml triethylamine in 1 liter water, pH=2.5 adjusted with ortho-phosphoric acid). The method was validated for specificity, linearity, precision, accuracy, robustness, and solution stability. The specificity of the method was determined by assessing interference from the placebo and by stress testing the drug (forced degradation). The method was linear over the concentration range 20–80 μg/ml (r2 = 0.999) with a Limit of Detection (LOD) and Limit of Quantitation (LOQ) of 0.1 and 0.3 μg/ml respectively. The accuracy of the method was between 99.2–100.5%. The method was found to be robust and suitable for the quantitative analysis of Dronedarone Hydrochloride in a tablet formulation. Degradation products resulting from the stress studies did not interfere with the detection of Dronedarone Hydrochloride so the assay is thus stability-indicating.
Keywords: Dronedarone Hydrochloride; Stability-indicating; HPLC Dronedarone Hydrochloride; Stability-indicating; HPLC
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. (CC BY 4.0).

Scifeed alert for new publications

Never miss any articles matching your research from any publisher
  • Get alerts for new papers matching your research
  • Find out the new papers from selected authors
  • Updated daily for 49'000+ journals and 6000+ publishers
  • Define your Scifeed now

SciFeed Share & Cite This Article

MDPI and ACS Style

DABHI, B.; JADEJA, Y.; PATEL, M.; JEBALIYA, H.; KARIA, D.; SHAH, A. Method Development and Validation of a Stability-Indicating RP-HPLC Method for the Quantitative Analysis of Dronedarone Hydrochloride in Pharmaceutical Tablets. Sci. Pharm. 2013, 81, 115-122.

Show more citation formats Show less citations formats

Article Metrics

Article Access Statistics

1

Comments

[Return to top]
Sci. Pharm. EISSN 2218-0532 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
Back to Top