Journal: Journal of Pharmacy Research
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)IndiaReceived on:16-03-2017; Revised on: 29-04-2017; Accepted on: 17-05-2017
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How to Cite my Article.
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
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