PROPUESTA DE MEJORA UTILIZANDO DISEÑO DE EXPERIMENTOS EN EL DESARROLLO DE TÉCNICAS ANALÍTICAS EN UN LABORATORIO FARMACÉUTICO

Abstract

This work arises from the need for quality control laboratory to optimize the instrumental analysis techniques in the development of drugs in a pharmaceutical company to reduce the analysis time of samples proposed by designing experiments a new method of analysis to optimize the process control and product release in compliance with the standards. To achieve this, made a series of experiments where we used a team of high resolution chromatography (HPLC) to determine the concentration of compound isosorbide dinitrate tablets presentation, changing the length of chromatographic column is currently using and modifying some factors influencing the chromatographic process to improve analysis times and improved use this technique in similar products. We analyzed the different factors influencing the chromatographic process for the modification of the factors to be used, by design of experiments allowed to determine the combination of factors that enable us to reduce the retention time of the compound. By reducing the compound retention time, reducing overall analysis time and consumption of solvents used in chromatography, making the process more efficient. Improved technique can be implemented in other similar tests