Development and Validation of a Method to Quantify Midazolam in a New Oral Formulation for Pediatric Use

Abstract

Aim: To develop an HPLC method to quantify midazolam in a new oral formulation for pediatric use. Methods: The stability of the new formulation was evaluated at different storage conditions and a preliminary assay of relative bioavailabil-ity was carried out in healthy volunteers. Results: The method of quantification was linear in the range of 5 to 60 µg·mL-1. The midazolam amount in the formulation remained stable for 90 days at 4 and 40˚C (in the dark) while at 25˚C was stable only for 14 days (exposed to light). Discussion: The relative bioavailability assay suggests that our preparation of mida-zolam in white chocolate reaches plasma levels similar to those induced by the apple juice formulation. Conclusion: This new white chocolate formulation masks the unpleasing flavour and has a more attractive presentation to the paediatric patient , which may be useful for children sedation and to ease its management by health carers.