Journal :   Asian Journal of Research in Chemistry

Volume No. :   5

Issue No. :  11

Year :  2012

Pages :   1381-1384

ISSN Print :  0974-4169

ISSN Online :  0974-4150


Registration

Allready Registrered
Click to Login

A Simple and Sensitive RP-HPLC Method for Estimation of Dronedarone in Bulk and Tablet Dosage Forms



Address:   K. Nageswara Rao1*, S. Ganapaty2 and A. Lakshmana Rao3
1K. G. R. L. College of Pharmacy, Bhimavaram- 534 202, A.P., India.
2A. U. College of Pharmaceutical Sciences, Visakhapatnam- 530 003, A.P., India.
3V. V. Institute of Pharmaceutical Sciences, Gudlavalleru- 521 356, A.P., India.
*Corresponding Author
DOI No:

ABSTRACT:
A simple, rapid, sensitive, accurate and precise HPLC method has been developed and validated for the estimation of Dronedarone in bulk and pharmaceutical dosage form. The method was carried out using XTerra Symmetry C18 (100 x 4.6 mm I.D., 5 µm particle size) column and mobile phase comprised of phosphate buffer pH 3.0 and acetonitrile in proportion of ratio 50:50 v/v and degassed in ultrasonic water bath. The flow rate was 0.8 mL/min and the detection wavelength was at 290 nm. The linearity was observed in the range of 10-60 µg/mL with a correlation coefficient of 0.999. The retention time of Dronedarone was 2.578 min. The method was validated as per the ICH guidelines for its linearity, precision, accuracy, specificity, limit of detection, limit of quantitation and by performing recovery studies. The percentage recovery of the drug Dronedarone was 99.0 % to 101.5 % from the tablet formulation. The proposed method is suitable for the routine quality control analysis for the estimation of Dronedarone in bulk and pharmaceutical dosage form.
KEYWORDS:
Dronedarone, Estimation, RP-HPLC, Validation.
Cite:
K. Nageswara Rao, S. Ganapaty, A. Lakshmana Rao. A Simple and Sensitive RP-HPLC Method for Estimation of Dronedarone in Bulk and Tablet Dosage Forms. Asian J. Research Chem. 5(11): Nov., 2012; Page 1381-1384.
[View HTML]      [View PDF]



Visitor's No. :   126945