Quantitative spectrophotometric determination of ivabradine hydrochloride in pharmaceutical formulations based on redox reaction using cerric(IV) ammonium sulphate

Document Type : Original Article

Authors

1 Department of Chemistry, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt.

2 Chemistry Department, Faculty of Science, Zagazig University, Zagazig, Egypt

3 Chemistry Department, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt.

4 Department of Chemistry, Faculty of Science, Zagazig University, Zagazig, Egypt.

Abstract

Simple, sensitive and accurate spectrophotometric methods has been developed for the assay of ivabradune hydrochloride (IVB) in bulk drug and pharmaceutical formulations. The proposed methods is based on oxidation reaction of IVB with a known excess of cerium(IV) ammonium sulphate (Ce(IV)) as an oxidizing agent in acid medium followed by determination of unreacted oxidant by adding a fixed amount of dye e.g. amaranth (AM), methylene blue (MB) and indigocarmine (IC) followed by measuring the absorbance at 520, 664 and 610 nm, respectively. The effect of experimental conditions were studied and optimized. The beer’s law was obeyed in the concentration ranges of 1.0-12, 1.0-18, and 1.0-12 μg mL-1 using AM, MB and IC dyes, respectively with a correlation coefficient ≥ 0.9995. The calculated molar absorptivity values are 2.4971 × 104, 1.8178 × 104 and 2.0833 × 104 L mol-1 cm-1 using AM, MB and IC dyes, respectively. The limits of detection and quantification were 0.29, 0.28 and 0.30 and 0.97, 0.93 and 1.0 µg mL-1 using AM, MB and IC methods, respectively. Intra-day and inter-day accuracy and precision of the methods have been evaluated. No interference was observed from the additives. The proposed methods were successfully applied to the assay of IVB in tablets preparations and the results were statistically compared with those of the reported method by applying Student’s t-test and F-test. The reliability of the methods was further ascertained by performing recovery studies using the standard addition method.

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