Journal: Journal of Pharmacy Research

Article Id: JPRS-PA-00001049
Title: Sensitive HPLC method for determination of related substance of levocetirizine dihydrochloride in solid oral formulations
Category: Pharmaceutical Analysis
Section: Research Article
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    A sensitive high performance liquid chromatography method has been developed and validated for the determination of Levocetirizine dihydrochloride related substances in solid oral formulation. Acetonitrile and diluted Sulphuric acid was used as a mobile phase for the elution and separation of Levocetirizine dihydrochloride and its related substance. Lichrocarrt Si60, 250 X 4.0, 5µ (Cartridge column) was used at 0.8 ml/min flow rate to achieve good resolution of the analyte and its impurities. Levocetirizine dihydrochloride was exposed to various stress conditions such as acid, base, oxidation & thermal degradations along with Placebo & Formulation. But it was found to be stable under all stress conditions. The detector linearity was established from concentrations ranging from 0.06 µg/ml to 0.60µg/ml for Levocetirizine dihydrochloride and 0.03 to 0.30 µg/ml for its impurities with a correlation co-efficient of 0.9999.The LOD and (LOQ) found to be in a range of 0.01 µg/ml and 0.06µg/ml for Levocetirizine dihydrochloride and 0.005 µg/ml and 0.03 µg/ml for related substances respectively. Sample Solutions stability was found stable for than 42 hours. The molecule was found stable in all the stress conditions and proved to be robust with respect to changes in flow rate and buffer composition. The proposed method is found to be sensitive, precise, rapid and reproducible.

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  • About the authors and Affiliations

    Author(s) Name:

    Yadav Birendra*, Sumit Yadav

    Affiliation(s) Name:

    Research and Development Department,Kusum Healthcare Pvt. Ltd., Bhiwadi-301707 Rajasthan, India

    *Corresponding author.
    Birendra Yadav
    C/o Kusum Healthcare Pvt. Ltd.
    Bhiwadi-301707 (Raj.)

    Received on: 15-06-2010; Revised on: 18-08-2010; Accepted on:13-09-2010

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    Yadav Birendra*, Sumit Yadav

    Title:Sensitive HPLC method for determination of related substance of levocetirizine dihydrochloride in solid oral formulations
    Journal:Journal of Pharmacy Research
    Vol(issue):3 (December)
    Page No: (2817-2820)
  • Experimental Methods Keywords

    Methodology:Sensitive HPLC method, Validation.
    Research Materials:levocetirizine dihydrochloride


HPLC Levocetirizine Related substance Validation.

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