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Journal :   Research Journal of Pharmacy and Technology

Volume No. :   4

Issue No. :  7

Year :  2011

Pages :   1115-1117

ISSN Print :  0974-3618

ISSN Online :  0974-360X


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A Validated Method for Development of Darifenacin Hydrobromide asActive Pharmaceutical Ingredient and Tablet Dosage form by UV- Spectroscopy



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.
3Dept. of Pharmaceutical Analysis, K.V.S.R Siddhartha College of Pharmaceutical sciences, Vijayawada, A.P,
*Corresponding Author
DOI No: Not Available

ABSTRACT:
The development and validation of an analytical ultraviolet (UV) spectroscopic method to quantify Darifenacin hydrobromide as a single active moiety in tablet was undertaken. The study was carried out as per USP and ICH guidelines. The proposed method was more sensitive in terms of per cent relative standard deviation (RSD), limit of detection (LOD), limit of quantification (LOQ), linearity and accuracy. Darifenacin Hydrobromide was estimated at 286.6 nm in 10%V/V 3N NaOH solution in methanol with linearity range of 10-100µg/mL, Detection limit 3.723 µg/mL, Quantification limit 11.28 µg/mL, molar absorptivity 4.116 X 103 L /mol/cm and correlation coefficient 0.9988. The recovery studies confirmed the accuracy of the method.
KEYWORDS:
Darifenacin hydrobromide, ICH guidelines, validation.
Cite:
Kathirvel S., Satyanarayana S.V., Devalarao G. A Validated Method for Development of Darifenacin Hydrobromide asActive Pharmaceutical Ingredient and Tablet Dosage form by UV- Spectroscopy. Research J. Pharm. and Tech. 4(7): July 2011; Page 1115-1117.
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