DEVELOPMENT AND VALIDATION OF RP-CATION EXCHANGE CHROMATOGRAPHIC METHOD FOR ESTIMATION OF DIVALENT METALLIC IONS FROM BULK AND PHARMACEUTICAL PRODUCTS
Dileep M. Bhosale*, Anna Pratima G. Nikalje
ABSTRACT
A novel, simple and rapid RP-HPLC method was developed for the
simultaneous determination of divalent Zn and Fe in pharmaceutical
products. The analysis was carried out on Whatman Partisil 10 SCX
(250 x 4.6) mm, 10μm column with 2.0 mL/min isocratic flow rate at
295 nm wavelength and the elution of both the components was
established within 15 minutes. The retention times of Zn and Fe were
about 8 and 9 minutes respectively. The proposed method was
validated as per current ICH guidelines for specificity, linearity,
robustness, limit of detection, limit of quantification, precision,
recovery and solution stability parameters. The exhaustive method
study was performed to indicate the stability indicating nature of method.
Keywords: Divalent metal ions, 1,10- Phenanthroline, Zinc (Zn2+), Iron (Fe2+), Cation Exchange.
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