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Journal of Analytical Methods in Chemistry
Volume 2014, Article ID 241035, 7 pages
http://dx.doi.org/10.1155/2014/241035
Research Article

A Comparative Study of Newly Developed HPLC-DAD and UHPLC-UV Assays for the Determination of Posaconazole in Bulk Powder and Suspension Dosage Form

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Alexandria University, 1 Khartoum Square, Azarita, Alexandria 21521, Egypt

Received 20 July 2014; Revised 6 August 2014; Accepted 8 August 2014; Published 3 September 2014

Academic Editor: Josep Esteve-Romero

Copyright © 2014 Dalia A. Hamdy and Tarek S. Belal. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objective. To develop and compare HPLC-DAD and UHPLC-UV assays for the quantitation of posaconazole in bulk powder and suspension dosage form. Methods. Posaconazole linearity range was 5–50 μg/mL for both assays. For HPLC-DAD assay, samples were injected through Zorbax SB-C18 (4.6 × 250 mm, 5 μm) column. The gradient elution composed of the mobile phase acetonitrile: 15 mM potassium dihydrogen orthophosphate (30 : 70 to 80 : 20, linear over 7 minutes) pumped at 1.5 mL/min. For UHPLC-UV assay, samples were injected through Kinetex-C18 (2.1 × 50 mm, 1.3 μm) column. The mobile phase composed of acetonitrile: 15 mM potassium dihydrogen orthophosphate (45 : 55) pumped isocratically at 0.4 mL/min. Detection wavelength was 262 nm in both methods. Results. The run time was 11 and 3 minutes for HPLC-DAD and UHPLC-UV assays, respectively. Both assays were linear () with CV% and % error of the mean <3%. Limits of detection and quantitation were 0.82 and 2.73 μg/mL for HPLC-DAD and 1.04 and 3.16 μg/mL for UHPLC-UV, respectively. The methods quantitated PSZ in suspension dosage form with no observable interferences. Conclusions. Both assays were proven sensitive and selective according to ICH guidelines. UHPLC-UV assay exhibited some economic and chromatographic separation superiority.