الفهرس | Only 14 pages are availabe for public view |
Abstract Regulations of the U.S. FDA and the EMA require full proof that drugs admitted to the market are consistent with safety and efficacy. Impurities and potential degradation products can cause changes in the chemical, pharmacological, and toxicological properties of drugs and thereby have a significant impact on product efficacy and safety. Accordingly, in modern analytical laboratories, degradation/impurity profiling is viewed as the most important tool for solving impurity-related problems, which is of vital importance to guarantee effectiveness and confirm the quality of medicines commercialized for the population. For this reason different analytical techniques were developed for determination of ROC, VEC and GRAN in the presence of their possible degradation products/impurities.One of the most challenges in the pharmaceutical science is to increase productivity, decrease costs and enhance the human health.The drug discovery and development process contribute to the reliable and quantitative measurement of therapeutic agents in various biological fluids. Drug analysis in biological systems provides valuable information about potential bioavailability, metabolism, toxicology, pharmacokinetics and/or pharmacodynamics. Our studied drugs (ROC and VEC) are used in surgical procedures as anaesthetics but they caused residual paralysis upon its administration in the intensive care unit. To reverse this effect, the doctors have to use Sugammdex injection (100 mg/mL) but it is very expensive. So this leads us to develop screen printed electrode (SPE) providing a real time monitoring at the point of care. These SPE successfully overcome the complexity of the direct injection of these biological fluids in most chromatographic system |