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Abstract

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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