Journal article Open Access
Oprea, Vasile; Cheptanaru, Constantin; Nistorica, Mihai; Giza, Cristina; Valica, Vladimir
Background: It is fundamental to develop new analysis methods for proving the utmost quality of medicines containing iron compounds. This study aims to determine whether the quantity of Fe (III) in dosage forms taken for analysis is equivalent to the concentration specified by the manufacturer.
Materials and methods: The concentration of Fe (III) in dosage forms taken for the study was determined using the standard addition method at acidic and alkaline pH using the sulfosalicylic acid as reagent. The obtained data was analyzed mathematically and graphically. The iodometric method of titration was applied to verify the obtained results.
Results: According to mathematical data analysis, the concentration of Fe (III) in the Ferimax syrup was 45.00 ± 2.23 mg/5ml at acidic and 50.11 ± 0.5 mg/5ml at alkaline pH. Using the graphical method, the concentration of Fe (III) was 43.75 mg/5ml at acidic and 50.60 mg/5ml at alkaline pH. For Ferrum Lek, the Fe (III) concentration was 50.68 ± 0.73 mg/5ml and 50.60 mg/5ml at alkaline pH using the mathematical and graphical methods. The redox titration method showed that in the Ferimax syrup, the average mass of Fe (III) is 44.07±0.7 mg/5ml, and in Ferrum Lek – 50.36±0.26 mg/5ml.
Conclusions: The concentration of Fe (III) in Ferimax syrup in acidic medium was lower than the reference of the label, while in basic medium both Ferimax and Ferrum Lek syrups have the expected concentration.