Systematic Strategies in High-Performance Liquid Chromatography Method Development and Validation

This paper concerns the systematic strategies in high-performance liquid chromatography method development and validation. Currently, there is no single source and/or a lack of detailed recommendations on method validation that helps analytical scientists to perform validation in a systematic manner in pharmaceutical industry. Therefore industry depends on the scientist's knowledge and experience to develop simple and efficient methods of analysis. This is why much effort in this paper is focused on the development of validated methods in the pharmaceutical industry. Therefore, guidelines were given for analytical development and validation in this field; the methyl p-hydroxybenzoate and propyl p-hydroxybenzoate was used as model. In addition, a rapid method using HPLC coupled with photdiode array detection was developed and validated for the simultaneous determination of methyl p-hydroxybenzoate and propyl p-hydroxybenzoate in a liquid pharmaceutical sample.