Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

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

Hassan Akhtar Alhazmi^1,2 , Zia ur Rehman¹

¹Department of Pharmaceutical Chemistry, College of Pharmacy; ²Substance Abuse Research Centre, Jazan University, Postal Code 45142, Jazan, Saudi Arabia.

For correspondence:- Hassan Alhazmi Email: haalhazmi@jazanu.edu.sa Tel:+966541433344

Accepted: 27 January 2019 Published: 28 February 2019

Citation: Alhazmi HA, ur Rehman Z. A fast and validated chromatographic method for simultaneous determination of deferoxamine and D-penicillamine via chelate formation with metal ions in bulk and dosage forms. Trop J Pharm Res 2019; 18(2):357-364 doi: 10.4314/tjpr.v18i2.19

© 2019 The authors.
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Abstract

Purpose: To develop a chromatographic method for the determination of deferoxamine (DFX) and D-penicillamine (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