VALIDATION HPLC METHOD FOR THE DETERMINATION OF CLONIDINE HYDROCHLORIDE RESIDUES FROM PHARMACEUTICAL MANUFACTURING EQUIPMENT
Journal Title: Вісник Одеського національного університету. Хімія - Year 2014, Vol 19, Issue 3
Abstract
Highly sensitive HPLC method of determination of clonidine hydrochloride trace amounts for validation cleaning process of the pharmaceutical equipment has been proposed. The developed method has been validated on the following parameters: specificity, linearity, precision, limit of detection and limit of quantification. The calibration curve was linear over the concentration range of 0.1-6.0 mg / ml, the limit of detection is 0.026 μg/ml. It has been found that clonidine hydrochloride solutions are stable for 48 hours. Effectiveness of the method of sampling is more than 95%.
Authors and Affiliations
A. V. Yegorova, G. A. Fedosenko, K. O. Vityukova, S. N. Kashutskуy, G. V. Maltsev
Keywords
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- EP ID EP408575
- DOI 10.18524/2304-0947.2014.3(51).40364
- Views 72
- Downloads 0
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