DEVELOPMENT AND VALIDATION OF THE HPLC METHOD FOR THE ANALYSIS OF DOXAZOSIN IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORMSAbstract
A simple, economic, selective, precise, and accurate High Performance liquid Chromatographic method for the analysis of Doxazosin in bulk drug and pharmaceutical formulations was developed and validated in the present study. The mobile phase consists of a mixture of Methanol and Potassium Dihydrogen Orthophosphate in the proportion 60: 40. And adjust the pH to 5.0 ± 0.05 with sodium hydroxide solution. This was found to give a sharp peak of Doxazosin at a retention time of 4.484 min. HPLC analysis of Doxazosin was carried out at a wavelength of 251nm with a flow rate of 1.0mL/min. The linear regression analysis data for the calibration curve showed a good linear relationship with a regression coefficient of 0.999 in the concentration range of 50 ppm to 150 ppm. The linear regression equation was y =28.34x-16.91. The developed method was employed with a high degree of precision and accuracy for the analysis of Doxazosin. The developed method was validated for accuracy, precision, robustness, detection and quantification limits as per the ICH guidelines. The wide linearity range, accuracy, sensitivity, short retention time and composition of the mobile phase indicated that this method is better for the quantification of Doxazosin.
N.V.S. Naidu*, M. Rama Mohan Reddy and P. Suguna
Department of Chemistry, S.V. University, Tirupati-517502, Andhra Pradesh, India
18 April, 2012
04 May, 2012
27 July, 2012
01 August, 2012