Application of chemometrics using direct spectroscopic methods as a QC tool in pharmaceutical industry and their validation.

This present review described the application of chemometrics using direct spectroscopic methods at the quality control (QC) laboratory of Pharmaceutical Industries. Using chemometrics methods, all QC assessments during the fabrication processes of the drug preparations can be well performed. Chemometrics methods have some advantages compared to the conventional methods, i.e., non-destructive, can be performed directly to intake samples without any extractions, unnecessary performing stability studies, and cost-effective. To achieve reliable results of analyses, all methods must be validated first prior to routine applications. According to the current Pharmacopeia, the validation parameters are specificity/selectivity, accuracy, repeatability, intermediate precision, range, detection limit, quantification limit and robustness. These validation data must meet the acceptance criteria, that have been described by the analytical target profile (ATP) of the drug preparations.