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Sci. Pharm. 2012, 80(2), 317-328; doi:10.3797/scipharm.1111-11

Stability-Indicating HPLC Method for Posaconazole Bulk Assay

1
Departamento de Produção e Controle de Medicamentos, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS). Av. Ipiranga, 2752. Sala 406. CEP 90610-000, Porto Alegre/RS, Brazil
2
Laboratório de Desenvolvimento e Controle de Qualidade de Medicamentos, Universidade Federal do Pampa (UNIPAMPA). BR 472 km 585. CEP 97500-970, Uruguaiana/RS, Brazil
*
Author to whom correspondence should be addressed.
Received: 11 November 2011 / Accepted: 12 March 2012 / Published: 12 March 2012
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Abstract

A stability-indicating liquid chromatographic (LC) method was developed for the determination of posaconazole in bulk. Chromatographic separation was achieved using an isocratic elution in a reversed-phase system, with a mobile phase composed of methanol-water (75:25, v/v), at 1.0 mL min−1 flow. Samples were exposed to degradation under thermal, oxidative and acid/basic conditions, and no interference in the analysis was observed. System suitability was evaluated and results were satisfactory (N = 4,900.00 tailing factor 1.04; RSD between injections = 0.65). The retention time of posaconazole was about 8.5 min and the method was validated within the concentration range 5–60 μg mL−1 (r = 0.9996). Adequate results were obtained for repeatability (RSD % = 0.86–1.22), inter-day precision (RSD % = 1.21) and accuracy (98.13% mean recovery). Robustness was also determined to be satisfactory after evaluation. The proposed method was successfully applied to posaconazole bulk quantification, showing the method is useful for determination of the drug in routine analysis.
Keywords: Posaconazole; Triazoles; HPLC; Stability-indicating assay; Bulk; Stress conditions Posaconazole; Triazoles; HPLC; Stability-indicating assay; Bulk; Stress conditions
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

GARCIA, C.V.; COSTA, G.R.; MENDEZ, A.S.L. Stability-Indicating HPLC Method for Posaconazole Bulk Assay. Sci. Pharm. 2012, 80, 317-328.

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