Abstract

VASQUEZ RIBERA, LILIAN  and  COPARE MORALES, YOVANA. Validación retrospectiva del método analítico por espectrofotometría para la cuantificación del acetaminofeno(Industrias Farmacéuticas IFA). Univ. Cienc. Soc. [online]. 2012, n.7, pp. 34-43. ISSN 8888-8888.

A retrospective validation of a spectrophotometric method was conducted on the premises of Pharmaceutical Industries (IFA), which allowed the quantification of the paracetamol (acetaminophen) active ingredient as a finished product in tablet dosage form. It was determined through the use of statistical calculations such as lower line adjustment, equa-tion of the line, statistical significance, confidence limits, coeffidents of variation, standard deviation, averages of mea-surements, statistical tables, etc., (each with the amount of sample required for each parameter under study) that the method meets all validation requirements proposed for the chemical control of quality, this method proved to be linear, precise, accurate, specific, and sensitive as well as being quick and easy. Nowadays validation methods, processes, etc., are very important, because they allow greater reliability in the results, mainly when working with pharmaceutical products, where it is necessary to obtain data and experimental results that demonstrate the fitness for intended use.

Keywords : Retrospective validation; Analytical method; Spectrophotometry; Quantification of acetaminophen.