According to the World Health Organization (WHO), substandard, spurious, falsely labeled, falsified, and counterfeit (SSFFC) pharmaceuticals are a prominent issue in developing countries such as Nepal. This led to the development of the Paper Analytical Device (PAD) which screens for the presence, or lack of, the active pharmaceutical ingredient (API) in WHO essential drugs. Omeprazole is responsible for proton pump inhibition and combats the symptoms of acid reflux disease (GERD), an illness common in developing countries. In order to validate and quantify the results from the PADs, 110 samples of omeprazole were collected from various regions in Nepal during Summer 2016. All omeprazole samples were prepared in a 10 mg/mL solution with HPLC grade 2-propanol and analyzed using reverse phase LC-MS, with a Phenomenex Kinetex C-18 column. Data indicated the sample preparation method produced consistent and reproducible results, that every omeprazole pill contained some amount of the API, and that some brands and regions produced data that were consistently lower than the promised amount of API. Results will be compared with the USP method for omeprazole.

Validation by LC-MS of paper analytical devices of suspect nepali omeprazole

255th National Meeting (2018)

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