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Tropical Journal of Pharmaceutical Research

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A fast and validated chromatographic method for simultaneous determination of deferoxamine and Dpenicillamine via chelate formation with metal ions in bulk and dosage forms

Hassan A. Alhazmi, Zia ur Rehman

Abstract


Purpose: To develop a chromatographic method for the determination of deferoxamine (DFX) and Dpenicillamine (D-PEN) by improving ultra violet (UV)-absorption via complex formation with Fe2+ and Cu2+ metal ions.

Methods: Chromatographic analysis was performed by Waters RP-HPLC system using a Symmetry® C (18) column with a mobile phase comprising 0.1 % formic acid and methanol (95:5 v/v). For complexation process, drug and metal ion solution were mixed in a ratio of 1:5 and the resulting complex directly analyzed. Validation and system suitability parameters (including chromatographic parameters) were determined.

Results: DFX-Fe2+ and D-PEN-Cu2+ complexes showed good UV absorption at 260 nm and were easily determined by the newly developed HPLC method. The developed method showed linearity over the concentration range of 8 - 96 μgmL-1 (R2 > 0.999 for DFX and > 0.99 for D-PEN). Precision and accuracy were also within acceptable limits (100.0 ± 2.0 %).

Conclusion: The developed method is robust and validated, and satisfies all the system suitability requirements as per ICH guidelines. DFX injection and D-PEN capsule dosage forms can be successfully analysed with the proposed method. The method is simple, fast and cost-effective for the analysis of D-PEN and DFX individually, or simultaneously in bulk drugs as well as in capsule and parenteral formulations, using UV-detector.

Keywords: Deferoxamine, D-penicillamine, Chelate formation, Metal ions, HPLC, Dosage forms




http://dx.doi.org/10.4314/tjpr.v18i2.19
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