Development and Validation of A Cerium (Iv)–Indigo Carmine-Based Indirect Spectrophotometric Method for The Quantitative Determination of Selected Pharmaceutical Formulations

Authors: Rajitha Balusani

DOI: https://doi.org/10.37082/IJIRMPS.v11.i3.233170

Short DOI: https://doi.org/hb8xxk

Country: India

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Abstract: A simple, sensitive, and cost-effective indirect spectrophotometric method was developed and
validated for the quantitative determination of Ciprofloxacin, Pantoprazole Sodium Sesquihydrate, Atorvastatin Calcium, and Rosuvastatin Calcium in bulk drugs and pharmaceutical formulations. The method is based on the oxidation of the selected drugs with a measured excess of Cerium (IV) Ammonium Sulphate in Sulphuric acid medium, followed by the spectrophotometric determination of the residual oxidant using indigo carmine dye. Experimental conditions, including acid concentration and reaction time, were systematically optimized to achieve maximum sensitivity and stable analytical response. The proposed method exhibited excellent linearity within the respective Beer’s law ranges and was validated according to International Council for Harmonisation (ICH) guidelines for accuracy, precision, limit of detection, limit of quantification, robustness, and ruggedness. Recovery studies demonstrated excellent accuracy and confirmed the absence of interference from common pharmaceutical excipients. Owing to its simplicity, rapid analysis, low operational cost, and reliable performance, the proposed method provides an efficient alternative to sophisticated instrumental techniques and is well suited for routine quality control analysis of pharmaceutical formulations.

Keywords: Indirect Spectrophotometry; Cerium (IV); Indigo Carmine; Pharmaceutical analysis; Method validation.

Paper Id: 233170

Published On: 2023-06-08

Published In: Volume 11, Issue 3, May-June 2023

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