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International Journal of Zoology and Applied Biosciences Research Article
HPLC method development and validation for the detection of unknown impurities in cetirizine hydrochloride drops
Rahul Shivarkar, Vidya Padvi, Toshika Nikam, Ritika Dhonge, Hemant Alhat, Vijaya Vichare and Shashikant Dhole
Year : 2026 | Volume: 11 | Issue: 4 | Pages: 15-23
Received on: 10/03/2026
Revised on: 19/03/2026
Accepted on: 27/05/2026
Published on: 01/07/2026
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Rahul Shivarkar, Vidya Padvi, Toshika Nikam, Ritika Dhonge, Hemant Alhat, Vijaya Vichare and Shashikant Dhole( 2026).
HPLC method development and validation for the detection of unknown impurities in cetirizine hydrochloride drops
. International Journal of Zoology and Applied Biosciences, 11( 4), 15-23.
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Abstract
Cetirizine hydrochloride oral liquid formulations require stability-indicating impurity profiling to ensure quality and safety. To develop and validate a robust RP-HPLC method for detection of unknown impurities. Separation achieved on Intersil ODS 3V C18 (4.6 × 250 mm, 5 µm) using acetonitrile: 1-heptanesulphonate sodium buffer: sulfuric acid (25:75:0.3 v/v/v), flow rate 1.0 mL/min, detection at 230 nm. Validation performed as per ICH Q2(R2) guidelines. Excellent linearity (r²=0.9999) from 1.25-150%. Significant degradation under oxidative (10.837%) and photolytic (6.445%) conditions. Precision (%RSD<2%), recovery (98.91-100.41%), LOD (0.0524 µg/ml), LOQ (0.1587 µg/ml), robustness and stability met acceptance criteria. The method is stability-indicating and suitable for routine quality control and stability studies.
Keywords
Method validation, Related substances, Stability-indicating method, HPLC, Forced degradation.
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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.
