Determination of cetirizine dihydrochloride, related impurities and preservatives in oral solution and tablet dosage forms using HPLC

AMY Jaber, HA Al Sherife, MM Al Omari… - … of pharmaceutical and …, 2004 - Elsevier
AMY Jaber, HA Al Sherife, MM Al Omari, AA Badwan
Journal of pharmaceutical and biomedical analysis, 2004Elsevier
An HPLC method was developed and validated for the determination of cetirizine
dihydrochloride (CZ) as well as its related impurities in commercial oral solution and tablet
formulations. Furthermore, two preservatives associated with the drug formulations, namely,
propyl (PP) and butylparabens (BP) were successfully determined by this method. The
chromatographic system used was equipped with a Hypersil BDS C18, 5μm column (4.6×
250mm) and a detector set at 230nm in conjunction with a mobile phase of 0.05 M …
An HPLC method was developed and validated for the determination of cetirizine dihydrochloride (CZ) as well as its related impurities in commercial oral solution and tablet formulations. Furthermore, two preservatives associated with the drug formulations, namely, propyl (PP) and butylparabens (BP) were successfully determined by this method. The chromatographic system used was equipped with a Hypersil BDS C18, 5μm column (4.6 × 250mm) and a detector set at 230nm in conjunction with a mobile phase of 0.05M dihydrogen phosphate:acetonitrile:methanol:tetrahydrofuran (12:5:2:1, v/v/v/v) at a pH of 5.5 and a flow rate of 1ml min−1. The calibration curves were linear within the target concentration ranges studied, namely, 2×102–8×102μg ml−1 and 1–4μg ml−1 for CZ, 20–100μg ml−1 for preservatives and 1–4μg ml−1 for CZ related impurities. The limits of detection (LOD) and quantitation (LOQ) for CZ were, respectively, 0.10 and 0.34μg ml−1 and for CZ related impurities were in the ranges of 0.08–0.26μg ml−1 and 0.28–0.86μg ml−1, respectively. The method proved to be specific, stability indicating, accurate, precise, robust and could be used as an alternative to the European pharmacopoeial method set for CZ and its related impurities.
Elsevier
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