Abstract Many different strategies of high performance liquid chromatographic method development are being used today. This overview describes a strategy for the systematic development of High performance liquid chromatographic (HPLC) methods. It is an analytical tool which is able to separate, detect and quantify the drug, its various impurities and drug related degradants that can form on synthesis or storage. HPLC involves the understanding of chemistry of drug substance and facilitates the development of the analytical method. Many chromatographic parameters were evaluated in order to optimize the method. Appropriate mobile phase, stationary phase, column, column size, temperature, wavelength and gradient must be found that affords suitable compatibility and stability of drug as well as impurities and degradants. In this paper we have discussed the different physical and chemical parameters that govern the HPLC process and operation and suggested method development for the most optimum conditions based on the analytes.
Keywords HPLC, Chromatography, Drug, Optimization, Validation.