Analytical Method Development and Validation for Iron and Ascorbic Acid in Ferrous bisglyciante Effervescent Tablets by Colorimetry and RP-HPLC.

Vasantharaju SG

Abstract


A sensitive colorimetric and reverse phase high performance liquid chromatographic method was developed for estimation of total iron and ascorbic acid in ferrous bisglycinate effervescent tablets.

 

A colorimetric method was developed for total iron using 1,10 phenanthroline as complexing agent analysed at 510 nm. The validated data showed that the method was linear over a range of 0.625-3.75 μg/ml (r2= 0.999) and its accuracy ranged from 98-102%. The RSD value for method precision was 0.49%.

 

A RP -HPLC method was developed for ascorbic acid employing Inertsil octadecylsilyl groups column (250×4.6mm;5μm) 20mM concentrated potassium dihydrogen phosphate (pH 2.5) and methanol (97:03) was used as mobile phase. An isocratic programme was followed using 0.3M hydrochloric acid with 5% OPA as diluent. Detection was done by using photo diode array detector at 245nm with the flow rate of 1ml/min. Validated data showed that the method was linear over a range of 4.0-60.0 μg/ml (r2= 0.999). The accuracy of the method ranged from 100-102%. The RSD value for method precision was 0.8%.

 

The developed analytical methods were validated as per ICH guidelines Q2(R1) for system suitability, specificity, linearity, accuracy and precision. The results were within acceptable limits. 


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