Title: Global Perspectives and Emerging Dimensions of Multidisciplinary Research
Chief Editors: Dr. Jagdish Kumar Sahu and Ms. Machado Sneha John
Associate Editors: Dr. Sree Lakshmi Ammanamanchi and Dr. Divya R. Patel
Co-Editors: Mr. Hruthik J. R and Dr. Shishira Srinivasa
ISBN: 978-93-7183-027-0
Chapter: 17
DOI: https://doi.org/10.59646/833/17
Author: Ms. Meena M
Abstract
Drug content uniformity is an important quality-control test used to determine whether individual dosage units contain the drug substance in a consistent amount relative to the labeled claim. Uniform distribution of the active pharmaceutical ingredient (API) is essential because variation between individual tablets or capsules may result in inconsistent dosing. Pharmacopoeial requirements describe content uniformity as an assessment based on the assay of individual dosage units, with acceptance criteria applied to the resulting individual values and acceptance value. Several analytical instruments can be used for drug-content determination depending on the drug substance, dosage form and validated analytical method. Common laboratory techniques include UV–Visible spectrophotometry and high-performance liquid chromatography (HPLC), while modern pharmaceutical manufacturing increasingly uses near-infrared (NIR) spectroscopy and UV imaging for rapid or non-destructive measurements. Recent research has demonstrated the use of UV/Vis spectroscopy for in-line monitoring and UV imaging for high-throughput tablet content measurement. This journal describes the principle, major apparatus, sample preparation, analytical procedure, calculations, results and applications of instrumental methods used for drug content uniformity analysis.