Risk-Based Selection of Active Pharmaceutical Ingredients in the Development of HPLC and NIR Methods for Pediatric Preparations

The lack of appropriate formulations for the pediatric population often requires the manipulation of adult dosage forms in hospital settings, a practice that can lead to errors that impact patient safety. This study aimed to support the quality control of pediatric preparations by developing and validating analytical methods for the quantification of active pharmaceutical ingredients (APIs) in the tablets used for their elaboration. Folic acid and phenobarbital were selected based on a risk analysis as the priority APIs to work with. High-performance liquid chromatography (HPLC) and Near-infrared (NIR) spectroscopy methods for the quantification of these APIs in commercially available products were developed and validated. NIR methods are presented as a rapid and non-destructive alternative that offers the possibility of determining the content of the same tablets that will be used to prepare the pediatric dilution. This could be considered as a promising analytical tool for drug quality control during the elaboration process of these preparations.