Analytical method validation

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

See also!

Applications of High Performance Liquid Chromatography

Applications of HPLC

Applications of HPTLC in Pharmaceutical Analysis

HPLC Instrumentation Chromatography advance

Waters HPLC

Method development in hplc - Chromatography advance

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Jose Hullgren (Laboratory Analist)

Hello to all readers, my name is Jose Hullgren, it is a pleasure to present you this website of my authorship, I am currently working as a laboratory analyst and for the last 10 years I have been working in the pharmaceutical industry. The main idea of this page is to provide relevant information in the field of the pharmaceutical industry above all. We also cover different areas of chemistry and sciences in general that we find interesting. Perfil Linkedin