Validation of a simple analytical method by UV-Spectroscopy, for the quantification of metformin in tablets, applied to dissolution profiles.

Abstract

In Mexico, Metformin (MTF) is an oral hypoglycemic drug that is part of the group of biguanides used as a first-line treatment for the management of Type 2 Diabetes Mellitus. In the Mexican pharmaceutical market, there is a wide variety of medicines containing this drug, hence the importance of evaluating the quality of the medicines sold in the country. One of the important chemical tests performed both in the drug development phase, and in the quality evaluation criteria during its production, is the dissolution test. This is the test where it simulates in vitro, the time it takes for a given drug to pass into its soluble form, thus establishing its release time. The dissolution test to assess bioavailability in vitro has already been included in several official regulations, as a quality control method that allows predicting the behavior of the drug in the pharmaceutical form after its administration. The aim of this work was to validate a simple and reliable analytical method to quantify MTF in immediate-release tablets by UV spectroscopy, for a comparative study of in vitro dissolution profiles. In dissolution medium of 0.68% potassium monobasic phosphate at pH 6.8, adjusted with sodium hydroxide, the method demonstrated linearity in the range of 2 to 16 µg/L. The parameters evaluated complied with the provisions of the national and international guidelines for the validation of analytical methods; therefore, the analytical method meets the requirements for the quantification of Metformin in dissolution studies.