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


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 bioavailability 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℃ (in the dark) while at 25℃ was stable only for 14 days (exposed to light). Discussion: The relative bioavailability assay suggests that our preparation of midazolam 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.

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C. Pérez, J. Pacheco, J. Pérez, H. Olguín, B. Mendiola, R. Álvarez, J. Zamora and Á. Guerra, "Development and Validation of a Method to Quantify Midazolam in a New Oral Formulation for Pediatric Use," American Journal of Analytical Chemistry, Vol. 3 No. 8, 2012, pp. 552-558. doi: 10.4236/ajac.2012.38073.

Conflicts of Interest

The authors declare no conflicts of interest.


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