Development and Validation of A Visible Spectrophotometric Method for the Assay of Selected Pharmaceutical Formulations
Author(s): Rajitha Balusan
Publication #: 2606052
Date of Publication: 09.06.2024
Country: India
Pages: 1-10
Published In: Volume 10 Issue 3 June-2024
DOI: https://doi.org/10.62970/IJIRCT.v10.i3.2606052
Abstract
A reliable, sensitive, and precise spectrophotometric method was established for the determination of Cetirizine Dihydrochloride (CTZ), Imatinib Mesylate (ITM), and Voriconazole (VCZ) in bulk materials and tablet formulations. The method relies on the oxidation of the drugs by an excess of N-Bromosuccinimide (NBS) in acidic medium, with unreacted NBS quantified via Methylene Blue. Validation parameters, including linearity, accuracy, precision, %RSD, LOD, LOQ, robustness, and ruggedness, were assessed. The method exhibited excellent recoveries (97–100%) with %RSD values below 2%, confirming high reliability. Comparative statistical evaluation using Student’s t-test and F-test showed no significant differences from reference procedures. The developed approach is practical for routine quality control in pharmaceutical laboratories.
Keywords: Spectrophotometry, N-Bromosuccinimide, Methylene Blue, Pharmaceutical Analysis, Method Validation.
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