Method validation is the process that is used to verify the analytical process use of a particular method, an analytical instrument is proper for its intended use. Method validation results are used to judge the quality, quantity, consistency, and reliability of particular results. Method validation in chromatography must be carried out as per the validation protocol is given by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) or The United States Pharmacopeia (USP) and British Pharmacopoeia (BP). The protocol includes the process and criteria of acceptance for all protocol.As per ICH guidelines, below listed are the method validation parameters of pharmaceutical analysis.
- Accuracy
- Precision
- Specificity
- Limit of Detection (LOD)
- Limit of Quantitation (LOQ)
- Linearity
- Range
- Robustness
- Rougdness
- System Suitability