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Determination of cetirizine dihydrochloride, related impurities and preservatives in oral solution and tablet dosage forms using HPLC.
J Pharm Biomed Anal. 2004 Oct 29; 36(2):341-50.JP

Abstract

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, 5 microm column (4.6 x 250 mm) and a detector set at 230 nm in conjunction with a mobile phase of 0.05 M dihydrogen phosphate:acetonitrile:methanol:tetrahydrofuran (12:5:2:1, v/v/v/v) at a pH of 5.5 and a flow rate of 1 ml min(-1). The calibration curves were linear within the target concentration ranges studied, namely, 2 x 10(2) - 8 x 10(2) microg ml(-1) and 1-4 microg ml(-1) for CZ, 20-100 microg ml(-1) for preservatives and 1-4 microg ml(-1) for CZ related impurities. The limits of detection (LOD) and quantitation (LOQ) for CZ were, respectively, 0.10 and 0.34 microg ml(-1) and for CZ related impurities were in the ranges of 0.08-0.26 microg ml(-1) and 0.28-0.86 microg 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.

Authors+Show Affiliations

Jaber AM
Chemistry Department, King Fahid University of Petroleum and Minerals, Dhahran 31261, Saudi Arabia. amjaber@kfupm.edu.sa
Al Sherife HA
No affiliation info available
Al Omari MM
No affiliation info available
Badwan AA
No affiliation info available

MeSH

CalibrationCetirizineChromatography, High Pressure LiquidDrug ContaminationDrug StabilityHistamine H1 AntagonistsPharmaceutical SolutionsPreservatives, PharmaceuticalReference StandardsReproducibility of ResultsSpectrophotometry, UltravioletTablets

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15496327

Citation

Jaber, A M Y., et al. "Determination of Cetirizine Dihydrochloride, Related Impurities and Preservatives in Oral Solution and Tablet Dosage Forms Using HPLC." Journal of Pharmaceutical and Biomedical Analysis, vol. 36, no. 2, 2004, pp. 341-50.
Jaber AM, Al Sherife HA, Al Omari MM, et al. Determination of cetirizine dihydrochloride, related impurities and preservatives in oral solution and tablet dosage forms using HPLC. J Pharm Biomed Anal. 2004;36(2):341-50.
Jaber, A. M., Al Sherife, H. A., Al Omari, M. M., & Badwan, A. A. (2004). Determination of cetirizine dihydrochloride, related impurities and preservatives in oral solution and tablet dosage forms using HPLC. Journal of Pharmaceutical and Biomedical Analysis, 36(2), 341-50.
Jaber AM, et al. Determination of Cetirizine Dihydrochloride, Related Impurities and Preservatives in Oral Solution and Tablet Dosage Forms Using HPLC. J Pharm Biomed Anal. 2004 Oct 29;36(2):341-50. PubMed PMID: 15496327.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Determination of cetirizine dihydrochloride, related impurities and preservatives in oral solution and tablet dosage forms using HPLC. AU - Jaber,A M Y, AU - Al Sherife,H A, AU - Al Omari,M M, AU - Badwan,A A, PY - 2004/02/15/received PY - 2004/06/29/revised PY - 2004/07/03/accepted PY - 2004/10/22/pubmed PY - 2005/4/29/medline PY - 2004/10/22/entrez SP - 341 EP - 50 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 36 IS - 2 N2 - 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, 5 microm column (4.6 x 250 mm) and a detector set at 230 nm in conjunction with a mobile phase of 0.05 M dihydrogen phosphate:acetonitrile:methanol:tetrahydrofuran (12:5:2:1, v/v/v/v) at a pH of 5.5 and a flow rate of 1 ml min(-1). The calibration curves were linear within the target concentration ranges studied, namely, 2 x 10(2) - 8 x 10(2) microg ml(-1) and 1-4 microg ml(-1) for CZ, 20-100 microg ml(-1) for preservatives and 1-4 microg ml(-1) for CZ related impurities. The limits of detection (LOD) and quantitation (LOQ) for CZ were, respectively, 0.10 and 0.34 microg ml(-1) and for CZ related impurities were in the ranges of 0.08-0.26 microg ml(-1) and 0.28-0.86 microg 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. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/15496327/Determination_of_cetirizine_dihydrochloride_related_impurities_and_preservatives_in_oral_solution_and_tablet_dosage_forms_using_HPLC_ DB - PRIME DP - Unbound Medicine ER -