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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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.
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