Journal :   Asian Journal of Research in Chemistry

Volume No. :   4

Issue No. :  6

Year :  2011

Pages :   946-948

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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Development and Validation of a RP-HPLC Method for Estimation of Darifenacin Hydrobromide in Bulk and in Tablet Dosage Form



Address:   Kathirvel S.1, Satyanarayana S.V.2 and Devalarao G.3*
1Department of Pharmaceutical analysis, Hindu College of Pharmacy, Amaravathi road, Guntur, A.P, India.
2Department of Chemical Engineering, JNTU College of Engineering, Anantapur, A.P, India.
3Department of Pharmaceutical Analysis, K.V.S.R Siddhartha College of Pharmaceutical sciences, Vijayawada, A.P, India.
*Corresponding Author
DOI No:

ABSTRACT:
The present work describes a simple, precise and accurate HPLC method for estimation of darifenacin hydrobomide in bulk and in tablet dosage form. The separation was achieved by using Waters Sunfire C 18 (4.6 X 250 mm) 5µm particle size column. The mobile phase consisted of 0.02M potassium dihydrogen phosphate buffer pH 7 adjusted with triethylamine: acetonitrile: methanol in the ratio of 40:30:30(v/v/v). Detection was carried out at 280 nm. The retention time of darifenacin hydrobromide was found to be 4.2 min respectively. The Limit of detection and limit of Quantification was found to be 2.112 µg/mL and 6.400 µg/mL respectively. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (10-100 µg/mL), precision, accuracy and specificity according to ICH guidelines. The proposed method provides an accurate and precise quality control tool for routine analysis of darifenacin hydrobromide in bulk and in tablet dosage form.
KEYWORDS:
Darifenacin hydrobromide, HPLC, method development, validation.
Cite:
Kathirvel S., Satyanarayana S.V., Devalarao G.. Development and Validation of a RP-HPLC Method for Estimation of Darifenacin Hydrobromide in Bulk and in Tablet Dosage Form. Asian J. Research Chem. 4(6): June, 2011; Page 946-948.
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