A Review on: Analytical Method Development and Validation and It’s QbD Approach

A Review on: Analytical Method Development and Validation and It’s QbD Approach

Registration ID: IJNRD_182840

Published ID: IJNRD2209043

DOI: Click Here to Get

Kishor S. Arote , Darshan A. Salade , Nilesh V. Patil , Dr. Vikas V. Patil , Amol R. Pawar

Method development, Validation, HPLC, QbD, Analytical QbD

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.

Published Paper   E-Certificate

"A Review on: Analytical Method Development and Validation and It’s QbD Approach", IJNRD - INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (www.IJNRD.org), ISSN:2456-4184, Vol.7, Issue 9, page no.365-378, September-2022, Available :https://ijnrd.org/papers/IJNRD2209043.pdf

Volume 7 Issue 9, September-2022

Pages : 365-378

Paper Reg. ID: IJNRD_182840

Published Paper Id: IJNRD2209043

Downloads: 000121236

Research Area: Pharmacy

Country: Nashik, Maharashtra, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2209043.pdf

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2209043

Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)

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

Publisher: IJNRD (IJ Publication) Janvi Wave

This work is licensed under a Creative Commons Attribution 4.0 International License and The Open Definition

Call For Paper - Volume 10 | Issue 8 | August 2025

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INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (IJNRD) aims to explore advances in research pertaining to applied, theoretical and experimental Technological studies. The goal is to promote scientific information interchange between researchers, developers, engineers, students, and practitioners working in and around the world. IJNRD will provide an opportunity for practitioners and educators of engineering field to exchange research evidence, models of best practice and innovative ideas.

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Paper Submission Open For: August 2025

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