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VOL. 10, ISSUE 2 (2025)
Development and validation of hplc method for analysis of chlorpheniramine maleate & levocetirizine in syrup formulation
Authors
Ashwini D Uke, Dr. AV Chandewar, Dr. AP Dewani
Abstract
A simple, rapid, accurate, precise and
validated High-performance Liquid Chromatographic method for the simultaneous
estimation of Chlorpheniramine Maleate and Levocetirizine HCl in bulk and
Multicomponant formulation. The Reversed-phase liquid chromatographic analysis
was performed on a Phenomenex -C18 column (250×4.6 mm i.d., 5 µm particle size)
column with mobile Phase 0.01 M Disodium Hydrogen Phosphate Buffer PH 3.3 and
Acetonitrile (98:02 v/v) and column temperature at 40°C. The flow rate of the
mobile phase was adjusted to 1.0 ml/min and the injection volume was 20 μl.
Detection was performed at 230 nm. The retention time for CPM and LCET were
9.569 min and 14.096 min respectively. The method was validated and shown to be
linear for CPM and LCET in 12.5-37.5 µg/mL (r2=0.998) and 25-75 µg/mL
(r2=0.998) respectively. The proposed methods were successfully applied to the
determination of Chlorpheniramine Maleate and Levocetirizine HCl in tablets,
with high percentage of recovery, good accuracy and acceptable precision. Different
analytical performance parameters such as Linearity, Precision, Accuracy, Limit
of Detection, Limit of Quantitation and Robustness were determined according to
International Conference on Harmonization ICH Q2B guidelines. The developed RP-
HPLC method is suitable for estimation of Chlorpheniramine Maleate and
Levocetirizine HCl in tablet formulation. Hence this method can be used in
quality control for routine analysis of the finish drug product.
Pages:49-54
How to cite this article:
Ashwini D Uke, Dr. AV Chandewar, Dr. AP Dewani "Development and validation of hplc method for analysis of chlorpheniramine maleate & levocetirizine in syrup formulation". International Journal of Research in Pharmacy and
Pharmaceutical Sciences, Vol 10, Issue 2, 2025, Pages 49-54
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