Browsing by Author "De La Torre Chara, Stephania"
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Item Validación para la determinación de trazas de detergente citrajet usando como trazador ácido cítrico(Universidad Santiago de Cali, 2024) De La Torre Chara, Stephania; Ríos Acevedo, Jhon Jairo (Director)In the development of this analytical validation, the detection and quantification of the Citrajet detergent, used in the cleaning of drug production equipment at the TECNOFAR plant, was sought, a citric acid standard was used as a tracer (molecule present in the complex mixture of the detergent) Selectivity was evaluated using the Purity Threshold, which was higher than the Purity angle, confirming that the peaks are chromatographically pure. Linearity was verified by an ANOVA test, obtaining an F-value of 78381, which, when compared with the F-Crit (4,7), allowed the null hypothesis to be rejected and to conclude that concentration and response follow a linear relationship. The accuracy was evaluated using Horwitz's coefficient of variation, obtaining values of 0.2% and 2.6%, which allowed us to conclude that the method is accurate. The limit of quantification (LOQ) was determined by the signalto-noise ratio of the solution: LOD was greater than 3 for each of the injections and for the LOQ it was greater than 10, meeting the acceptance criteria. Accuracy was assessed by retrieval for the three levels assessed to be in the range between 90.0% -110.0%, with a minimum value of 97.2% and a maximum value of 104.9%. The intermediate accuracy was verified by the recovery of analysts’ 1 and 2, which were within the established recovery range and the recovery factor was less than 2%. In addition, recovery was evaluated on each surface and swab, recovery was greater than 50% and RSD was less than 2%. The quantification of the detergent obtaining a percentage of citric acid was 15.7%. Compatibility was evaluated in the filtered solutions, obtaining the lowest result of 97.8% and the highest of 104.2%s meeting the recovery criterion. In surface stability, it was established that the maximum stability time of the solution is until the last time in which the results are within the range between 95% and 105% with respect to the concentration of the standard at time 0, the results of the samples remained stable in solution for 60 hours, in swabbing for 24 hours and on the surface for 24 hours. And finally, the robustness test was carried out with different systems, obtaining those systems 1, 2 and 5 are within the acceptance criteria and systems 3, 4 and 6 are not within the acceptance criteria. Based on all the above obtained, it is concluded that the validation complies with all the planned parameters, guaranteeing a robust, reliable and reproducible method that can be used in the routine of Tecnofar's quality control area.