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Validation of direct method to quantify dexamethasone in human aqueous humor by LC-MS/MS
Mônica Siqueira Ferreira1, Cláudio Roberto Marquez1, Danieli Almeida Dos Santos1
1Centro Avançado de Estudos e Pesquisas - CAEP, P.O. Box: 245, 13087-567, Campinas, SP, Brazil.
Aim:
Dexamethasone (Dex) has been used for the treatment of ocular diseases, presenting concentrations up to 150 ng/ml in the biological matrix. Drug sampling has been performed from aqueous humor (AH), which the volume varies from 50 to 200 μl, becoming a challenge for analytical analyses.
Results:
We developed and validated a direct and sensitive method by LC-MS/MS for Dex measurement in human AH, using water as surrogate matrix to reduce the sample volume applied in some validation assays. With accuracies of 99.6% and precision within 15% in the range of 0.1-150 ng/ml, Dex had an 87-day stability.
Conclusion:
Our method is robust and sensitive enough to be applied in bioequivalence studies with human AH using only 20 μl of biological sample.
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