Impact of Inadequate Storage on the Stability and Quality of Metformin Hydrochloride Medication

Abstract

The 2021 report numbers from the International Diabetes Federation revealed a worrying trend of increasing diabetes prevalence worldwide. In this context, this work takes an experimental approach to verify whether consumers' improper handling of medication storage affects the stability of metformin hydrochloride tablets subjected to temperature and humidity variations different from those described in the manufacturer's leaflet. The application of the High-Performance Liquid Chromatography (HPLC) technique, typically used for quality control in the pharmaceutical industry, can demonstrate through the analysis of organic impurities whether temperature and humidity effects cause the appearance of these impurities in the active pharmaceutical ingredient present in the tablets. This analysis allows for the identification and quantification of such impurities that may be present in the samples. The stability test follows the guidelines of RDC N° 318 of 2019 from the National Health Surveillance Agency (ANVISA), which provides for stability testing, and the correct application of the method brings greater safety and reliability to medication consumers. According to the obtained results, metformin hydrochloride tablets exposed to temperature and humidity variations inside a vehicle's glove compartment over periods of 0, 14, 28, and 42 days did not present impurity peaks. Therefore, there was no degradation of the active ingredient over the tested periods, indicating that the stability of the finished product was maintained during these periods.