Journal: Journal of Pharmacy Research

Article Id: JPRS-PCS-00001917
Title: Analytical method development and validation for the estimation of ambroxol HCL in its tablet dosage form by UV-spectrophotometry
Category: Pharmaceutics
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    Objective: To develop and validate simple, accurate, rapid, precise, reproducible, and cost-effective spectrophotometric method for the quantitative estimation of ambroxol hydrochloride in its tablet dosage form. Materials and Methods: The developed ultraviolet spectrophotometric method for the quantitative estimation of ambroxol hydrochloride is based on measurement of absorption at maximum wavelength of 305 nm using methanolic water (1:9) as a solvent. The stock solution of ambroxol hydrochloride was prepared, and subsequent suitable dilution was made using distilled water to obtain calibration curve. The standard solution of ambroxol hydrochloride shows absorption maxima at 305 nm. Results: The drug obeyed beer lambert’s law in the concentration range of 20-100 µg/ml with regression 0.999 at 305 nm. The overall % recovery was found to be present in between 100.17% and 100.38% which reflects that the method was free from the interference of the impurities and other excipients used in the formulation. The low value of % relative standard deviation (RSD) was indicative of accuracy and reproducibility of the method. The % RSD for interday and intraday precision was found to be 0.1179 and 0.1177, respectively, which is <2% hence proved that method is precise. Conclusion: The results of analysis have been validated as per International Conference on Harmonization guidelines. The developed method can be adopted in routine analysis of ambroxol hydrochloride in tablet dosage form as well bulk dosage form.

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  • About the authors and Affiliations

    Author(s) Name:

    V. Sarovar Reddy1*, A. Susmitha2

    Affiliation(s) Name:

    1Department of Pharmaceutics, Annamacharya College of Pharmacy, New Boyanapalli, Rajampet, Kadapa Dist,Andhra Pradesh, India,

    2Department of Pharmaceutical Analysis, Annamacharya College of Pharmacy, New Boyanapalli,Rajampet, Kadapa Dist, Andhra Pradesh, India

    *Corresponding author: V. Sarovar Reddy, Assistant Professor, Department of Pharmaceutics, Annamacharya College of Pharmacy, New Boyanapalli, Rajampet, Kadapa Dist, A.P., India.

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    Author:

    V. Sarovar Reddy1*, A. Susmitha2

    Title:Analytical method development and validation for the estimation of ambroxol HCL in its tablet dosage form by UV-spectrophotometry
    Journal:Journal of Pharmacy Research
    Vol(issue):11 (August)
    Year:2017
    Page No: (921-926)
  • Experimental Methods Keywords

    Methodology:Method development, Ultraviolet spectrophotometry, Validation
    Research Materials:Ambroxol hydrochloride

Keywords

Ambroxol hydrochloride International Conference on Harmonization Guidelines Methanol Method development Ultraviolet spectrophotometry Validation

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