Abstract

This article contains the details of the validation of the analytical method for the quantification of acetaminophen, in this case to apply to the uniformity test of content to tablets of 500 mg, by the technique of UV spectroscopy at a wavelength of work 242 nm, using hydrochloric acid as solvent at a concentration of 0.1 M. the parameters evaluated were linearity, accuracy, repeatability and intermediate precision, strictly following the guidance and validation policy Costa Rican Accreditation Entity (ECA) for a modified standardized method.

All evaluated parameters yielded satisfactory results so it is considered that the method is linear, precise and accurate for the purpose it was developed; in this case to test for content uniformity in its first stage where the specification is that the acceptance value (AV) calculated not greater than L1 = 15, 10 doses analyzed individually according to USP 38.

Keywords: method validation; quality control; ultraviolet spectrophotometry; acetaminophen; paracetamol