Development and Validation of a Stability-Indicating LC Method to Quantify Hydrochlorothiazide in Oral Suspension for Pediatric Use |
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Authors: | Monika Piazzon Tagliari Hellen Karine Stulzer Fabio Seigi Murakami Gislaine Kuminek Bruno Valente Paulo Renato Oliveira Marcos Antonio Segatto Silva |
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Affiliation: | (1) Centro de Ciências da Saúde, Departamento de Ciências Farmacêuticas, Universidade Federal de Santa Catarina (UFSC), Campus Universitário Trindade, Bloco K, sala 207, Florianópolis, SC, 88040-900, Brazil |
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Abstract: | A stability-indicating reversed-phase high-performance liquid chromatography (LC) method was developed and validated for the determination of hydrochlorothiazide in an oral suspension. Isocratic chromatography was performed on a C18 column with 0.1 M sodium phosphate buffer pH 3.0/acetonitrile (70:30 v/v) as mobile phase, at a flow rate of 1.3 mL min−1, and UV detection at 254 nm. The method was linear (r 2 = 0.9998), accurate (mean recovery = 100.3%), and precise (RSD <2%). It was also validated for specificity and robustness. The method was successfully applied for the quality control analysis of a new pharmaceutical formulation of HCTZ for pediatric use. |
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Keywords: | Column liquid chromatography Stability-indicating Validation Pediatric oral suspension Hydrochlorothiazide |
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