Validated Analytical Methods For Determination Of Active Ingredients From Bulk Drugs And Pharmaceutical Dosage Forms

Method validation has received considerable attention in literature and from industrial committees and regulatory agencies.

The International Conference on Harmonization (ICH) of technical requirements for the registration of pharmaceuticals for human use has developed a consensus text on the validation of analytical procedures. The document includes definition of different validation parameters. The United States Environmental Protection agency (US EPA), Resource Conservation and Recovery Act (RCRA). The American Association of Official Analytical Chemist (AOAC), United States Environmental Protection Agency (USP) and other scientific organizations provide methods that are validated through multi-laboratory studies1.

The United States Food and Drug Administration (US FDA) has proposed guidelines on submitting sample and analytical data for methods validation. The United States Pharmacopoeia (USP) has published specific guidelines for method validation and compound evaluation2. read more