Calificación del disolutor ATG Dissolution Systems de Qualipharm Laboratorio Farmacéutico y Validación del método de disolución

Abstract

The Qualification of the Dissolver ATG Dissolution System of Qualipharm Pharmaceutical Laboratory and the Validation of the Dissolution Method was developed in the Quality Control Laboratory of Qualipharm Pharmaceutical Laboratory in the city of Quito. By means of a planning in which a direct investigation of the parameters of acceptance in equipment qualification and validation of methods described in the United States Pharmacopoeia 34 (USP 34) was used. In the Installation Qualification and in the Operation Qualification, the visual and operational verification of the ATG Dissolutor was used; for the Performance Qualification, the dissolution technique of prednisone USP RS 10 mg described in USP 34 was used. For the validation of the method, the determination techniques for Linearity, Specificity, Accuracy, Precision and Robustness described in USP 34 were also developed, applying the dissolution of 500 mg Levetiracetam tablets with a new technique under development using Perkin-Elmer Spectrophotometer. With 34.90 % of prednisone, the approval of the Performance Qualification is achieved, thus obtaining the total qualification of the ATG Dissolver. With the values of Specificity showing that there is no placebo reading, Linearity with a value of r = 0.997, Accuracy with a repeatability of 108.17% of Levetiracetam and CV of 0.736 and with an intermediate precision in its recovery percentage of 99, 79%, Accuracy with a value of 101.26% of Levetiracetam and with a CV of 0.775, Robustness to temperature change with a deviation of 0.388 and when varying the agitation speed with a deviation of 0.001. All these results are within the acceptance criteria achieving the Validation of the Dissolution Method.