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Sci. Pharm.
Volume 81
Issue 1
10.3797/scipharm.1209-15
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Article

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

by
Batuk DABHI
1,*,
Yashwantsinh JADEJA
1,
Madhavi PATEL
1,
Hetal JEBALIYA
1,
Denish KARIA
2 and
Anamik SHAH
1
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.
Sci. Pharm. 2013, 81(1), 115-122; https://doi.org/10.3797/scipharm.1209-15
Submission received: 18 September 2012 / Accepted: 5 November 2012 / Published: 5 November 2012
Versions Notes

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

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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. https://doi.org/10.3797/scipharm.1209-15

AMA 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. Scientia Pharmaceutica. 2013; 81(1):115-122. https://doi.org/10.3797/scipharm.1209-15

Chicago/Turabian Style

DABHI, Batuk, Yashwantsinh JADEJA, Madhavi PATEL, Hetal JEBALIYA, Denish KARIA, and Anamik SHAH. 2013. "Method Development and Validation of a Stability-Indicating RP-HPLC Method for the Quantitative Analysis of Dronedarone Hydrochloride in Pharmaceutical Tablets" Scientia Pharmaceutica 81, no. 1: 115-122. https://doi.org/10.3797/scipharm.1209-15

APA Style

DABHI, B., JADEJA, Y., PATEL, M., JEBALIYA, H., KARIA, D., & SHAH, A. (2013). Method Development and Validation of a Stability-Indicating RP-HPLC Method for the Quantitative Analysis of Dronedarone Hydrochloride in Pharmaceutical Tablets. Scientia Pharmaceutica, 81(1), 115-122. https://doi.org/10.3797/scipharm.1209-15

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