Determinación del contenido de magaldrato en comprimidos masticables que se expenden en la ciudad de Guayaquil

Abstract

Magaldrate is an antacid used to treat gastrointestinal disorders associated with hyperacidity, such as gastritis and gastroesophageal reflux disease (GERD). Its therapeutic efficacy depends directly on the appropriate content of the active ingredient, making it essential to ensure compliance with quality specifications. This research aimed to determine the magaldrate content in chewable tablets sold in the city of Guayaquil and evaluate their compliance with the specifications established by the USP. A non-probabilistic, purposive, quota sampling method was used. Three brands were analyzed, considering three lots from each brand. Magaldrate content was determined by acid-base titration, and this method was also compared with atomic absorption spectrophotometry for the quantification of aluminum and magnesium. The results showed that all analyzed samples met the acceptance range of 90–110% established by the USP. Although statistically significant differences were identified between some lots and brands, these did not compromise regulatory compliance. The comparison between methods showed adequate analytical agreement, confirming that atomic absorption can be used as a complementary technique to the volumetric method for evaluating magaldrate content. Overall, the results indicate that the analyzed products meet current pharmacopoeial specifications.