DETERMINATION OF RIVASTIGMINE HYDROTARTRATE RESIDUES ON PHARMACEUTICAL MANUFACTURING EQUIPMENT SURFACES BY HPLC AND LUMINESCENCE METHODS

Abstract

Highly sensitive HPLC methods of determination of rivastigmine hydrotartrate trace amounts for cleaning of the pharmaceutical equipment have been proposed. The developed methods have been validated on the following parameters: specificity, linearity, precision, limit of detection and limit of quantification. The calibration curves were linear over the concentration range of 0,5-50,0 μg / ml (HPLC) and 0,5-20,0 μg / ml (Lum), the detection limits are 0,38 μg / ml and 0,48 μg / ml respectively. The effectiveness of the method of sampling is 83%. It is found that these methods allow to obtain comparable results. Luminecsent method in comparison with the HPLC has the following advantages: less labor intensity, rapidity and lower reagent consumption.

Keywords

• високоефективна рідинна хроматографія
• люмінесценція
• ривастигміну гідротартрат