HPLC is the dominant separation technique to detect, separate and quantify the drug. A number of chromatographic parameters were analyzed to optimize the method like sample pretreatment, choosing mobile phase, column, detector selection. The objective of this article is to review the method development, optimization and validation. HPLC method development depends on chemical structure of the molecules, synthetic route, solubility, polarity, pH and pKa values, and functional groups activity etc. Validation of HPLC method as per ICH Guidelines gives information regarding various stages and knowing characteristics like Accuracy, specificity, linearity limit of detection, limit of quantification.