Journal: Journal of Pharmacy Research

Article Id: JPRS-PA-00001722
Title: QbD Approach for Analytical Method Development and Validation of Melatonin by spectroscopic Method
Category: Pharmaceutical Analysis
Section: Research Article
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  • Abstract

    Spectroscopic method was developed according to Quality by Design(QbD) approach as per ICH Q8 (R2) guidelines for Melatonin. QbD approach was carried out by varying various parameters and these variable parameters were designed into Ishikwa diagram. The critical parameters were determined by using principle component analysis as well as by observation. The estimated critical parameters in zero order spectroscopic method were Methanol, sample preparation tablet, wavelength 222 nm, slit width: 1.0, scan speed medium, and sampling interval: 0.2, The above methods were validated according to ICH Q2(R1) guidelines. Proposed methods can be used for routine analysis of Melatonin in tablet dosage form as they were found to be robust and specific.

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  • About the authors and Affiliations

    Author(s) Name:

    Bhusnure O.G.*, Gandge N.V., Gholve S.B., Giram P.S.,

    Affiliation(s) Name:

    Channabasweshwar Pharmacy College, Department of Quality Assurance, Latur(MS), India.

    *Corresponding author
    Dr. Bhusnure O.G., M. Pharm, Ph.D.
    Professor and Head
    Department of Quality Assurance,
    Channabasweshwar Pharmacy College,
    Kava Road, Latur-413512, Dist. Latur. (MS)India

    Received on:16-03-2017; Revised on: 29-04-2017; Accepted on: 17-05-2017

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    Author:

    Bhusnure O.G.*, Gandge N.V., Gholve S.B., Giram P.S.,
    Title:QbD Approach for Analytical Method Development and Validation of Melatonin by spectroscopic Method
    Journal:Journal of Pharmacy Research
    Vol(issue):11 (May)
    Year:2017
    Page No: (464-471)

  • Experimental Methods Keywords

    Methodology:UV Spectrophotometry, ICH Q8 (R2), Ishikawa Diagram, Critical Parameters, Quality by Design (QbD).
    Research Materials:Melatonin

Keywords

Melatonin UV Spectrophotometry ICH Q8 (R2) Ishikawa Diagram Critical Parameters Quality by Design (QbD).

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