Abstracting & Indexing
Dr. Liliya Logoyda is working as an Associate Professor of the Department of Pharmaceutical Chemistry of I. Ya.
Horbachevsky Ternopil State Medical University, Ukraine.
Development and testing of new analytical methods and validation of analytical methods. Most frequently, we are looking for a new method development for the following reasons: it is necessary to monitor reaction conversions and impurity levels in intermediates during the development of a new synthetic route of an active pharmaceutical ingredient (API); assay or purity method described in a corresponding pharmacopoeia is obsolete or does not comply with customer’s requirements; the
analytical method for purity or assay of API in a new drug product is simply not available; a final drug product represents a novel combination of APIs; no analytical method exists for determination of the particular auxiliary chemical of impurity.
According to the requirements of the SPU, methods of quantitative determination of medicines must be validated. The results obtained from method of validation, can be used to judge the quality, reliability and consistency of analytical results. Validation of analytical methods is also required by most regulations and quality standards that impact laboratories. Analytical methods of validation is essential for adherence to Current Good Manufacturing Practice and Good Laboratory Practice regulations. She has more more than 90 publications.
Affiliation: Department of Pharmaceutical Chemistry of I. Ya. Horbachevsky Ternopil State Medical University, Ukraine.