Validation of methods for the determination of medicinal substances using the example of voltamperometrical determination of atropine in eye drops and solutions for injections
At a Glance
Section titled āAt a Glanceā| Metadata | Details |
|---|---|
| Publication Date | 2023-01-01 |
| Journal | Visnyk of the Lviv University Series Chemistry |
| Authors | Olha Dushna, Liliya Dubenska |
| Institutions | Lviv University |
Abstract
Section titled āAbstractāValidation is an important component of the procedures that a laboratory must perform before implementing a new method of drug analysis. By the requirements of the European Pharmacopoeia and the State Pharmacopoeia of Ukraine, it is necessary to determine the following analytical characteristics for the analytical method: specificity, robustness, linearity, accuracy, precision, and their components. This work gives a short validation report of the proposed voltammetric method for determining atropine in eye drops and solutions for injections. The planar electrochemical cell with the working boron-doped diamond electrode was used. The developed method was validated according to the criteria of uncertainty, linearity, accuracy, and precision. Keywords: validation, ISO/IEC 17025, electrochemical methods, voltammetry, atropine.