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HPLC method development for analysis of a multi-component drug product

Developing a high performance liquid chromatography (HPLC) method for the analysis of compounds is a task that usually requires much expertise and is also extremely time-consuming. This becomes even more complex if the sample is a mixture of multiple components.  This poster reports development and validation of a stability-indicating HPLC method for a drug product with two API’s and 21 known impurities. The initial development work was approached by employing the quality by design principles outlined in the ICH guidelines Q8 and Q9. Based on the material, process and product attributes the method has to measure, the performance requirement for the HPLC method and optimum chromatographic conditions were identified. The optimum conditions are examined and further fine tuned during the development stage.
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