Development and validation of a rapid UV-HPLC method for the determination of anidulafungin in perfusion solution

Abstract

Background: Anidulafungin is an antifungal agent. The development of determination techniques can be a useful tool to realize stability and quality control studies.

Methods: The determination was performed on an analytical Mediterranea SEA18 (15x0.4 cm, 5 μm) C18 column at 35 ºC. The selected wavelength was 304 nm. The mobile phase was a mixture of 0.037 M sodium dihydrogen phosphate buffer, acetonitrile and methanol (40:50:10, v/v/v) at a flow rate of 2.0 mL min–1. Dasatinib (12.5 μg mL-1) was used as internal standard. Results: The assay enables the measurement of anidulafungin with a linear calibration curve (r2= 0.999) over the concentration range 15–300 μg mL-1. Accuracy, intra-day repeatability (n = 5), and inter-day precision (n = 3) were found to be satisfactory, being the accuracy 5.8% and precisions were intra-day and inter-day, 0.6% and 4.2%, respectively. Conclusions: A rapid, simple and sensitive high-performance liquid chromatography (HPLC) method with ultra violet detection has been developed for quantification of anidulafungin in perfusion solution. The retention time was clearly minor than the previous published HPLC determination methods of anidulafungin.