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International Journal of Zoology and Applied Biosciences Research Article
Development and validation of UV spectrophotometric method for the estimation of hydroxyzine hydrochloride in pharmaceutical dosage form
Vijaya Vichare, Krutika Chavan, Vaibhavi Chaskar, Madhuri More, Vrushali Tambe, Shashikant Dhole
Year : 2026 | Volume: 11 | Issue: 3 | Pages: 24-30
Received on: 18/01/2026
Revised on: 29/01/2026
Accepted on: 23/03/2026
Published on: 01/05/2026
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Vijaya Vichare, Krutika Chavan, Vaibhavi Chaskar, Madhuri More, Vrushali Tambe, Shashikant Dhole( 2026).
Development and validation of UV spectrophotometric method for the estimation of hydroxyzine hydrochloride in pharmaceutical dosage form
. International Journal of Zoology and Applied Biosciences, 11( 3), 24-30.
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Abstract
A simple, rapid, precise, and economical UV spectrophotometric method was developed and validated for the estimation of Hydroxyzine Hydrochloride in marketed tablet formulation. The method was based on the measurement of absorbance at 230 nm using distilled water as solvent. Hydroxyzine Hydrochloride exhibited linearity in the concentration range of 5–40 µg/mL with a correlation coefficient (r²) of 0.9986. The developed method was validated as per ICH Q2(R1) guidelines for parameters including linearity, accuracy, precision, specificity, robustness, limit of detection, and limit of quantification. The LOD and LOQ were found to be 0.179 µg/mL and 0.597 µg/mL, respectively. Accuracy studies showed satisfactory recovery of the drug, indicating the reliability of the method. Precision studies demonstrated %RSD values below 2%, confirming the precision of the method. Robustness studies revealed that minor deliberate variations in analytical conditions did not significantly affect the results, indicating method robustness. The proposed method was successfully applied for the assay of Hydroxyzine Hydrochloride in marketed tablets (Atarax® 10 mg), and the results were found to be within acceptable limits. The developed UV spectrophotometric method is simple, accurate, precise, robust, and suitable for routine quality control analysis of Hydroxyzine Hydrochloride in pharmaceutical formulations.
Keywords
UV spectrophotometry, Hydroxyzine Hydrochloride, Method development, Method validation, ICH Q2(R1).
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© The Author(s) 2025. This article is published by International Journal of Zoology and Applied Biosciences under the terms of the Creative Commons Attribution 4.0 International License (creativecommons.org), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
