Validación de un método analítico para la determinación de benzocaína y cloruro de cetilpiridinio en tabletas de disolución bucal en el Laboratorio Neofármaco CIA. LTDA

Abstract

The main objective of this research study was to demonstrate that the analytical method developed for the determination of Benzocaine (HPLC) and Cetylpyridinium Chloride (Volumetric Analysis), in buccal dissolution tablets produced by the Neofármaco laboratory, complies with the validation parameters considered by report 37 according to the World Health Organization (WHO). The physicochemical characteristics of Benzocaine and Cetylpyridinium Chloride in standard and placebo loaded, were essential for the development of the protocol and subsequent validation of the analytical method, identifying each of the validation parameters and acceptance criteria based on reports from the WHO, International Conference on Harmonization (ICH), Asociación española de farmacéuticos de la industria (AEFI) and United States Pharmacopoeia (USP); for bulk finished pharmaceutical products established in category I of the USP, 2023. Demonstrating that the analytical method developed is selective given that the percentage discrepancy is less than 5% for both Benzocaine in diluent A and B and Cetylpyridinium Chloride, linear because it has r > 999 and r^2 >999 for standard and placebo loaded at levels from 70% to 130% for Benzocaine in diluent A and B and levels from 12.5% to 150%, for Cetylpyridinium Chloride, accurate considering that the (RSD < 2.0) when evaluated against the standard; the accuracy of the method is based on the percentage recovery (98.145% for Benzocaine in diluent A, 100.749% Benzocaine diluent B and 99.631% for Cetylpyridinium Chloride), Suitable and Robust. Demonstrating that the developed, optimized, and validated method complied with all the validation parameters, based on the results obtained, being consistent and reproducible in the operating conditions established for Benzocaine and Cetylpyridinium Chloride in buccal dissolution tablets, achieving its execution for the quality control of the finished product Bucosept.