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Determination of Hydrochlorothiazide and Two Major Degradation Products by Stability Indicating High Performance Liquid Chromatography

Author(s):

Larissa Sakis Bernardi, Pedro Nicolau Severino Junior, Isabela Fanelli Barreto Biscaia, Maximiliano da Silva Sangoi, Vitor Todeschini, Cassiana Mendes, Marcos Antonio Segatto Silva and Paulo Renato Oliveira*   Pages 1 - 5 ( 5 )

Abstract:


Background: Hydrochlorothiazide (HCTZ) is a thiazide diuretic which comprises two sulfonamide groups. The literature is not clear regarding the identification of the chromatographic peaks of its two major related substances: chlorothiazide and 4-amino-6-chloro-1,3-benzenedisulfonamide (DSA). Methods: In the present study, a simple, sensitive, and selective HPLC method was developed and validated for the assay of HCTZ, Chlorothiazide and DSA. The method was carried out on a C18 column, maintained at 40 ºC. The mobile phase was composed of monobasic potassium phosphate buffer 0.02M pH 3.0/acetonitrile/methanol (82:9:9, v/v/v), run at a flow rate of 1.0 mL/min, and UV detection at 270 nm. Results: All related compounds including processing impurities and degradants from stressed samples were well separated from each other. The performance of this method was validated in accordance to the ICH guidelines and included specificity, linearity, limit of detection, limit of quantification, accuracy, precision, and robustness. Conclusion: Based on the results, the HCTZ degradation pathway was proposed and the validated HPLC method was successfully applied to the quantitative analysis of HCTZ in pharmaceutical formulations, contributing to improve quality control, to assure therapeutic efficacy and to clarify the literature.

Keywords:

hydrochlorothiazide, chlorothiazide, validation, HPLC, related substances

Affiliation:

Post Graduation Program in Pharmaceutical Sciences, Universidade Estadual do Centro Oeste, 85040-080 Guarapuava-PR, Post Graduation Program in Pharmaceutical Sciences, Universidade Estadual do Centro Oeste, 85040-080 Guarapuava-PR, Post Graduation Program in Pharmaceutical Sciences, Universidade Estadual do Centro Oeste, 85040-080 Guarapuava-PR, Post Graduation Program in Bioactive Products and Biosciences, Federal University of Rio de Janeiro, 27930-560 Macae-RJ, Post Graduation Program in Bioactive Products and Biosciences, Federal University of Rio de Janeiro, 27930-560 Macae-RJ, Grupo de Estudos em Materiais Polimericos (POLIMAT), Departamento de Química, Universidade Federal de Santa Catarina, 88040-900, Florianopolis-SC, Post-graduation Program in Pharmaceutical Sciences, Quality Control Laboratory, Universidade Federal de Santa Catarina, 88040-900, Florianopolis-SC, Post Graduation Program in Pharmaceutical Sciences, Universidade Estadual do Centro Oeste, 85040-080 Guarapuava-PR



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