Validation of the analytical method

Method validation is the process used to verify the use of the analytical process of a particular method; an analytical instrument is suitable for the use for which it is intended. The results of method validation are used to judge the quality, quantity, consistency and reliability of particular results. The validation of the method in chromatography must be carried out according to the validation protocol given by the International Council for the Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) or the United States Pharmacopeia (USP) and the British Pharmacopeia ( BP). The protocol includes the process and acceptance criteria for all protocols.

According to the ICH guidelines, the validation parameters of the pharmaceutical analysis method are presented below.

  • Precision
  • Precision
  • specificity
  • Limit of detection (LOD)
  • Limit of quantification (LOQ)
  • Linearity
  • Interval
  • Solidity
  • Suddenness
  • System suitability

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Limit of detection (LOD)

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