Volume 9

January-March 2017

RP-HPLC method development and validation for the determination of alfuzosin HCl in bulk and pharmaceutical dosage form

Umay Chen, Shadia Afrin, Antara Ghosh, Sujan Banik

Abstract:
The present study was undertaken to develop a simple, rapid, accurate and sensitive reverse phase HPLC method for determination of Alfuzosin HCl in bulk powder and pharmaceutical dosage form. The chromatographic separation was accomplished on Hypersill ODS (250×4.6mm, 5μm) column using a mobile phase methanol: water is 90:10 (v/v) at a column temperature of 25°C. The eluents were monitored at 244 nm and total run time was 5 min with a flow rate of 1 ml/min. The drug was well resolved on the stationary phase and the retention time was found as 1.3±0.89 min with injection volume of 20µl. The method was found to be linear at concentration ranges of 10-50μg/ml with correlation coefficient of 0.999. The method was validated for linearity, precision, robustness and accuracy as per ICH guidelines. The results of all the validation parameters were well within their acceptance values (%RSD <2.0 specified by the USP, ICH and FDA), which prove applicability of the proposed method for routine analyses and quality-control assay of Alfuzosin HCl in pharmaceutical preparations.

Keywords: Alfuzosin HCl, Bulk Powder, RP-HPLC, Tablets, Validation.