During the summer of 2016, suspect pharmaceutical drugs were collected from several regions, manufacturers, and pharmacies in Nepal. In recent years, the quality of pharmaceutical drugs in developing countries has presented a significant health concern. The World Health Organization recognizes these low quality drugs as substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) and deems them difficult to detect. Paper Analytical Devices were used to screen the collected Nepali pharmaceuticals. The goal was to validate the findings of the Paper Analytical Devices (PADs) and to quantitate the active pharmaceutical ingredients (API) of the collected Nepali medicines. To do so, standards of each drug were purchased from Tokyo Chemical Industry and U.S. tablets were donated to develop the sample preparation methods. These methods were further developed using Reverse Phase and HILIC Liquid Chromatography alongside Mass Spectrometry with a C18 column. The focus for this presentation is the method development and validation of PADs for two antibiotics, azithromycin and amoxicillin clavulanate. Various solvents, crushing techniques, and instrument parameters were tested to determine the optimal sample method for both pharmaceuticals. Multiple antibiotic samples collected from Nepal were tested using the finalized, reproducible sample preparation methods.

Validation by LC-MS of paper analytical devices of azithromycin and amoxicillin/clavulanate

255th National Meeting (2018)

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