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ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016
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Impact Factor : 8.76

Issue per Year : 12

Volume Published : 7

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Paper Title: A Review on: Analytical Method Development and Validation and It’s QbD Approach
Authors Name: Kishor S. Arote , Darshan A. Salade , Nilesh V. Patil , Dr. Vikas V. Patil , Amol R. Pawar
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Published Paper Id: IJNRD2209043
Published In: Volume 7 Issue 9, September-2022
Abstract: The top objective of any pharmaceutical industry is to produce products of necessary characteristic and quality reliably, in a cost-effective manner. The main aim of this review article was to check the development and validation of the procedure employed for the medication from the starting of the formulation to the complete commercial batch of product and different steps involved in method development by the QbD approach for analytical method development and describes the implementation of QbD in analytical procedure validation. High performance liquid chromatography is most accurate methods widely used for the qualitative and quantitative analysis of drug product. HPLC is an analytical tool which is able to detect, separate and quantify the drug, its various impurities and drug related degradants that can be generate on synthesis or storage. Method development is essential for discovery and evaluation of drugs in the pharmaceutical formulation. HPLC method development depends on chemical structure of the molecules, synthetic route, solubility, polarity, pH and pKa values, and functional groups activity etc. functional groups activity etc. Validation of HPLC method as per ICH Guidelines gives information regarding various stages and knowing characteristics like Accuracy, specificity, linearity, limit of detection, ruggedness, robustness limit of quantification. Quality by Design (QbD) is a methodology of pharmaceutical development, recommended by regulatory agencies like USFDA. QbD helps in building the quality of products by design through risk assessment at the early stage and defining the design space at the later stage QbD based product development enables the understanding of additional formulation aspects by using a scientific approach and quality risk management.
Keywords: Method development, Validation, HPLC, QbD, Analytical QbD
Cite Article: "A Review on: Analytical Method Development and Validation and It’s QbD Approach", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.7, Issue 9, page no.365-378, September-2022, Available :http://www.ijnrd.org/papers/IJNRD2209043.pdf
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ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
Publication Details: Published Paper ID:IJNRD2209043
Registration ID: 182840
Published In: Volume 7 Issue 9, September-2022
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Page No: 365-378
Country: Nashik, Maharashtra, India
Research Area: Pharmacy
Publisher : IJ Publication
Published Paper URL : https://www.ijnrd.org/viewpaperforall?paper=IJNRD2209043
Published Paper PDF: https://www.ijnrd.org/papers/IJNRD2209043
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ISSN: 2456-4184
Impact Factor: 8.76 and ISSN APPROVED
Journal Starting Year (ESTD) : 2016

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