The Distributed Pharmaceutical Analysis Laboratory (DPAL)* is a project focused on the analysis of drugs in Africa, to identify mis-labeled or mis-dosed pills. Metformin is a pharmaceutical that is widely taken by individuals with Type-II diabetes. At Niagara University, we have worked to validate an HPLC method to determine whether metformin pills are indeed metformin, if they are dosed correctly, and whether there may be degraded products in the metformin. Our HPLC method is based on USP procedures for metformin analysis, adding a gradient column washing step. After this method passed system suitability checks and was approved by the DPAL project, the authors and analytical lab students at Niagara University analyzed 30 metformin tablets from Kenya against a calibration curve. Of these, 28 were found to be within 10% error of the labeled dosages. The remaining two pills were determined to be other pharmaceuticals in their corresponding packaging, which had been mixed into the metformin samples at some point between purchase and analysis. We are currently studying the stability of standard metformin solutions when stored at room temperature, and in the refrigerator (4°C) and freezer (-80°C). We are also working on separating additional metformin related compounds (MRCs) from Metformin via HPLC, and on quantifying these MRCs. It is hoped that the stability evaluation and MRC study will streamline and expand the utility of our HPLC analysis of metformin pills in the future.

Distributed Pharmaceutical Analysis Laboratory (DPAL): Metformin analyzed via HPLC

256th National Meeting (2018)

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