A Review on HPLC Method Development and Validation

High-Performance liquid chromatography (HPLC) is widely recognized as the most commonly used separation technique for the detection, separation, and quantification of drugs. To optimize HPLC methods, various chromatographic parameters are evaluated, including sample pretreatment, choice of mobile phase, column selection, and detector type. This article aims to discuss the processes involved in method development, optimization, and validation. The development and validation of analytical methods are critical in the discovery, development, and manufacturing of pharmaceutical drugs, as well as in research involving humans and animals. HPLC is a dominant technique in separation science, where analytes are separated by passing through a column packed with micrometre-sized particles. To comply with good manufacturing practices (GMP), pharmaceutical industries are required to establish comprehensive validation policies outlining the approach to validation. This article focuses on the optimization of HPLC conditions and provides an overview of the introduction, principles, types, instrumentation, method development and validation processes in HPLC. The validation of HPLC methods provides critical information about various parameters such as range, linearity, specificity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), robustness, ruggedness and system suitability. These validation processes must adhere to regulatory guidelines, such as those outlined by the International Council for Harmonisation (ICH).