Development and validation of a stability indicating HPLC method to determine diltiazem hydrochloride in tablets and compounded capsules

Authors

  • Mateus Araújo Castro e Souza Universidade Federal de Minas Gerais; Faculdade de Farmácia; Departamento de Produtos Farmacêuticos
  • Carlos Eduardo de Oliveira Pereira Universidade Federal de Minas Gerais; Faculdade de Farmácia; Departamento de Produtos Farmacêuticos
  • Fernando Henrique Andrade Nogueira Universidade Federal do Rio Grande do Norte; Centro de Ciências da Saúde; Departamento de Farmácia
  • Gerson Antônio Pianetti Universidade Federal de Minas Gerais; Faculdade de Farmácia; Departamento de Produtos Farmacêuticos

DOI:

https://doi.org/10.1590/s2175-97902017000300041

Keywords:

Diltiazem hydrochloride/compounded capsules, Diltiazem hydrochloride/tablets, High performance liquid chromatography /method validation, Stability indicating method

Abstract

A stability indicating HPLC method to determine diltiazem hydrochloride (DTZ) in tablets and compounded capsules was developed and validated according to Brazilian and the International Conference on Harmonization (ICH) guidelines. The separation was carried out on a Purospher Star® C18 (150 x 4.6 mm i.d., 5 µm particle size, Merck Millipore) analytical column. The mobile phase consisted of a 0.05% (v/v) trifluoroacetic acid aqueous solution and a 0.05% trifluoroacetic acid methanolic solution (44:56, v/v). The flow rate was 1.0 mL.min-1 with a run time of 14 minutes. The detection of DTZ and degradation products (DP) was performed at 240 nm, using a diode array detector. The method proved to be linear, precise, accurate, selective, and robust, and was adequate for stability studies and routine quality control analyses of DTZ in tablets and compounded capsules.

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Published

2017-01-01

Issue

Vol. 53 No. 3 (2017)

Section

Articles

License

All content of the journal, except where identified, is licensed under a Creative Commons attribution-type BY.

The on-line journal has open and free access.

How to Cite

Development and validation of a stability indicating HPLC method to determine diltiazem hydrochloride in tablets and compounded capsules. (2017). Brazilian Journal of Pharmaceutical Sciences, 53(3), e00041. https://doi.org/10.1590/s2175-97902017000300041