Validação do método de quantificação do dodecilbenzeno sulfonato de sódio (DBSNa) e aplicação em estudo de estabilidade acelerada de sua solução detergente 1,5% (v/v)

Abstract

Cleaning in the pharmaceutical industry is carried out through diluted detergents. Dilution alters the expiration period and leads to recurrent manipulations and discards. Therefore, the aim was to validate the methodology for quantifying Sodium Dodecyl Benzene Sulfonate (DBSNa) and to conduct an accelerated stability study of its 1.5% (v/v) diluted detergent solution, monitoring content, pH, and appearance over 56 days under heating (40±2 °C) and cooling (2–8 °C) conditions to propose a storage period. The validation of the analytical method demonstrated selectivity, linearity, detection and quantification limits, precision, accuracy, and robustness suitable for the intended purpose, enabling its use in the stability study. After the study, the solution exhibited a pH close to neutral, a clear appearance, and statistical analysis of the content showed no significant alteration, suggesting stability. Thus, a period of 56 days was established, contributing to cost reduction and greater sustainability within the industry.