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

Autor: A. V. Yegorova, G. A. Fedosenko, Yu. V. Scrypynets, I. I. Leonenko, G. V. Maltsev, V. P. Antonovich
Jazyk: English<br />Russian<br />Ukrainian
Rok vydání: 2017
Předmět:
Zdroj: Vìsnik Odesʹkogo Nacìonalʹnogo Unìversitetu: Hìmìâ, Vol 22, Iss 1(61), Pp 67-78 (2017)
Druh dokumentu: article
ISSN: 2304-0947
2414-5963
DOI: 10.18524/2304-0947.2017.1(61).94713
Popis: 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.
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