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Spectrophotometric method for quantitative determination of iron (III) from iron polymaltose complex in pharmaceutical formulations.

A visible spectrophotometric method has been developed for the quantification of iron (III) from iron polymaltose complex in pure and in pharmaceutical preparations. The method is based on hydrolysis of iron polymaltose complex under acidic conditions and the formation of red colored chromogen with ammonium thiocyanate, which showed absorption peak at 471 nm. This absorption wavelength can be used for the determination of iron (III) from iron polymaltose complex. The limit of detection of iron polymaltose complex at 476 nm was 6.207 ng mL(-1). The calibration was linear in the range of 19.8-22.2 microg mL(-1). Analytical parameters such as stability, selectivity, accuracy and precision have been established for the method in HAEMOTYL syrup and evaluated statistically to assess the application of the method. The method was validated under the ICH and USP guidelines and found to comprise the advantages for simplicity, stability, sensitivity, reproducibility and accuracy for using as a method for the routine analysis of the drug in pharmaceutical formulations and in pharmaceutical investigations involving iron polymaltose complex.