Method Development and Validation of Alfuzosin HCl and Dutasteride in Pharmaceutical Dosage Form by RP-HPLC

International Journal of Novel Trends in Pharmaceutical Sciences,2015,5,3,95-101.
Published:June 2015
Type:Research Article
Authors:
Author(s) affiliations:

P. Madhusudhan1, M. Radhakrishna Reddy2, N. Devanna3,*

1Department of Chemistry, B.V. Raju Institute of Technology Narsapur, Medak, Telangana, India. 

2Department of Chemistry, Dayanandasagar Academu of Technology& Management, Bangalore, Karnataka, India. 

3Jawaharlal Nehru Technological University Kalikiri, Andhra Pradesh, India.

Abstract:

A simple, economic, rapid, precise and accurate reverse phase high pressure liquid chromatographic method was developed and validated for the simultaneous determination of Alfuzosin and Dutasteride in Pharmaceutical dosage form. The RP-HPLC separation was Performed on XterraC18 column (250mmL×4.6mmI.D×5μ) using mobile phase acetonitrile: phosphate buffer (pH-6.5): water (75:15:10v/v/v) at a flow rate of 0.8 ml/min at an ambient temperature. Quantitation by HPLC was achieved with UV detection at 245nm based on peak area with linear calibration curves at concentration ranges 5-25μg/ml for ALFU and 10-50 μg/ml for DUTA, respectively. The limit of detections (LOD) was 0.0045 μg/ml for ALFU and 0.03 μg/ml for DUTA. The developed method was validated in terms of accuracy, precision, linearity, robustness and results will be validated statistically according to ICH guidelines.

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Structure Alfuzosin Hydrochloride