Search academic texts

Information × Registration Number 0218U002409, 0117U003067 , R & D reports Title Development and validation of methods for detection of residual amounts of drugs after cleaning pharmaceutical equipment popup.stage_title Head Antonovich V.P., Registration Date 01-03-2018 Organization A.V. Bogatsky, Physico-Chemical Institute of the National Academy of Sciences of Ukraine popup.description2 The object of the study :- quality control of the purification of pharmaceutical equipment. A theoretical approach has been developed to determine the basic metrological characteristic of an analytical technique for quality control of equipment cleaning - the maximum allowable uncertainty of a measurement result based on the requirement for LQD, in accordance with the principle of insignificance, and validation criteria for checking linearity, namely, the requirement for a correlation coefficient, angular coefficient and free member of the linear regression. The possibilities of this approach are considered with the helpth of the example of the method for determining the residual amounts of dequalinium chloride on the surfaces of pharmaceutical equipment by the method of high performance liquid chromatography (HPLC). Highly sensitive chromatographic (HPLC) methods for the determination of trace amounts of certain medical preparations in washings for the purification of pharmaceutical equipment were made: pramexol dihydrochloride, fenspiride, clonidine (clonidine) hydrochloride, rosuvastatin calcium, levan, rivastigmine hydrotartrate, phenibut, paracetamol, guaifenizine, theophylline, cinchocaine hydrochloride (HPLC with mass spectral detecting), metamizole sodium (analgin), L-leucine, L-isoleucine, L-valine. The developed methods are validated according to the following indicators: specificity, linearity, accuracy, detection limit and limit of quantitative determination. Sphere of application:-pharmacy Product Description popup.authors А.В. Єгорова В.П.Антонович Г.В.Мальцев Г.О.Федосенко Н.П. Єфрюшина О.І. Теслюк О.М.Дехтяренко Ю.В.Скрипинець popup.nrat_date 2020-04-02 Close