DETERMINATION OF FAVIPIRAVIR RESIDUES ON THE SURFACES OF PHARMACEUTICAL MANUFACTURING EQUIPMENT BY HPLC, LUMINESCENCE AND SPECTROPHOTOMETRY

Abstract

Determination of active pharmaceutical ingredients (APIs) in washes from the surface of pharmaceutical equipment is necessary to prevent cross-contamination of the next batch of products. Highly sensitive methods of chromatographic (HPLC), luminescent (Lum) and spectrophotometric (SF) determination of antiviral drug favipivir (FAV) residues in washes during cleaning of pharmaceutical equipment have been developed. Chromatographic and luminescence recording conditions of favipiravir were optimized. The content of FAV in the washes (μg/wash) is determined according to the calibration curve. The proposed methods are validated by the following parameters: specificity, linearity, accuracy, limit of detection and limit of quantification. The coefficients of linear dependences in the studied concentration ranges correspond to the permissible values for the methods of determination of substances whose concentration in the sample is above the limit of quantitative determination. Calibration graphs are presented in concentration ranges 0.02-2.0 μg ml (HPLC), 0.3-3.5 μg/ ml (Lum) and 1.0-20.0 μg/ml (SP), the detection limits are 0.023 μg/ml, 0.12 μg/ml and 0.11 μg/ml, respectively. The degree of extraction of favipivir from applicators and surfaces of pharmaceutical equipment is more than 85 %. Luminescent and SP techniques have a number of advantages over HPLC: less complexity, expressiveness and lower consumption of reagents, while the HPLC method has a greater sensitivity. The developed methods can be recommended for determination of residual amounts of favipivir at quality control of cleaning of the pharmaceutical equipment.

Keywords

• високоефективна рідинна хроматографія
• спектрофотометрія
• люмінесценція
• очищення фармацевтичного обладнання
• фавіпіравір