High performance liquid chromatography (HPLC) is an essential analytical tool in assessing drug product. HPLC methods should be able to separate, detect, and quantify the various drugs and drug related degradants that can form on storage or manufacturing, detect and quantify any drugs and drug-related impurities that may be introduced during synthesis. Validation is the process of establishing the performance characteristics and limitations of a method and identification of the influences which

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... may change these characteristics and to what extent. This article discusses the strategies and the issues pertinent to designing HPLC method development and validation.