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Stability-indicating HPLC method for posaconazole bulk assay.

Cássia V Garcia1, Gislaine R Costa, Andreas S L Mendez

  • 1Departamento 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.

Scientia Pharmaceutica
|August 17, 2012
PubMed
Summary

A new stability-indicating liquid chromatographic method accurately quantifies posaconazole in bulk. This validated method is reliable for routine analysis and ensures drug quality.

Keywords:
BulkHPLCPosaconazoleStability-indicating assayStress conditionsTriazoles

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Analysis

Background:

  • Posaconazole is a critical antifungal agent requiring robust analytical methods for quality control.
  • Existing methods may lack the specificity or stability-indicating capabilities needed for comprehensive analysis.

Purpose of the Study:

  • To develop and validate a stability-indicating liquid chromatographic (LC) method for posaconazole determination in bulk.
  • To assess the method's suitability for routine quality control and stability studies.

Main Methods:

  • Utilized reversed-phase isocratic elution with a methanol-water mobile phase (75:25, v/v) at 1.0 mL/min flow rate.
  • Exposed posaconazole samples to thermal, oxidative, and acid/basic stress conditions to evaluate stability-indicating properties.
  • Validated the method for linearity, accuracy, precision (repeatability and inter-day), system suitability, and robustness.

Main Results:

  • The method demonstrated excellent linearity (r=0.9996) within the 5-60 μg/mL range.
  • Satisfactory system suitability (tailing factor 1.04, RSD 0.65%) and validation parameters were achieved.
  • High accuracy (98.13% mean recovery) and precision (RSD ≤ 1.22%) were confirmed across various conditions.

Conclusions:

  • The developed stability-indicating LC method is highly specific and accurate for posaconazole quantification.
  • The method is robust and suitable for routine analysis and quality control of posaconazole bulk drug.