OTIMIZAÇÃO E VALIDAÇÃO DE UM MÉTODO ESPECTROFOTOMÉTRICO PARA DETERMINAÇÃO DA SULFANILAMIDA NA FORMA FARMACÊUTICA LÍQUIDA

Abstract

Quality control in the pharmaceutical industry aims to ensure that products meet the required quality standards. The main advantages in this control are the optimization of processes, standardization of procedures, quality of the environment, raw material inputs and final products. Several trials are conducted to ensure the quality of medicines, preventing the viability of counterfeit medicine. For quantification of sulfanilamide in liquid pharmaceutical form, validated analytical methodologies should be used to generate reliable information about the sample. In view of the above, the present study aimed to optimize and validate an analytical method for the determination of sulfanilamide in liquid pharmaceutical form with spectrophotometric detection in the visible region. The method is based on the diazototion reaction of sulfamylamide with nitrous ion produced in situ and subsequent coupling with the chromogenic agent 8-oxiquinolino in basic medium. The experimental parameters were carefully studied and optimized through the univariate method. The analytical curve showed good linearity with concentration between 2.90 x 10-6 to 4.06 x 10-5 mol L-1 and correlation of 0.9999. Detection limits (6.60 x 10-9 mol L -1) and quantification (2.20 x 10-8 mol L -1) were below the concentration range investigated. For the matrix effect study, the standard addition method was used, where the recovery percentage was 100.7 to 102.0%. The method presented error of +2.8, and coefficient of variation of 0.1% for the sample with 95% confidence interval. The results obtained by the application of the method presented excellent results, showing that the method developed is accurate and accurate.