Lestyo Wulandari, Rinaldi Idroes, Teuku Rizky Noviandy, Gunawan Indrayanto
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. © 2022 Elsevier Inc.
Faculty of Pharmacy, Jember University, Jember, Indonesia; Department of Pharmacy, Banda Aceh, Indonesia; Department of Chemistry, Faculty of Mathematics and Natural Sciences, Syiah Kuala University, Banda Aceh, Indonesia; Department of Informatics, Faculty of Mathematics and Natural Sciences, Syiah Kuala University, Banda Aceh, Indonesia; Faculty of Pharmacy, Surabaya University, Surabaya, Indonesia
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