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  • A Comprehensive Review On Analytical Method Development And Validation
  • 1Department of Pharmaceutical quality Assurance, R. G, Sapkal College of Pharmacy, Anjaneri, Nashik-422212
    2Department of Pharmaceutical Chemistry, R. G, Sapkal College of Pharmacy, Anjaneri, Nashik-422212
    3Department of Pharmacology, R. G, Sapkal College of Pharmacy, Anjaneri, Nashik-422212

Abstract

The top objective of any pharmaceutical industry is to produce products of necessary characteristic and quality reliably, in a cost-effective manner. Development of a method is essential for discovery, development, and evaluation of medicines in the pharmaceutical formulation. 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. At the point when an analytical technique is applied to produce outcomes for the quality of medicine associated samples, it is necessary that the outcomes are reliable. In the pharma industry, validation policy is documented for how to perform validation, types of validation and validation policy are complied with the necessities of good manufacturing practice (GMP) regulations. Validation is very important for the effective running of the pharmaceutical firms. At every stage from raw material to the finished, stability, everywhere validation was performed.

Keywords

Validation, Method development, Limit of quantitation, Limit of detection, Linearity, Robustness, Ruggedness

Reference

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Photo
Amol Amrutkar
Corresponding author

Department of Pharmaceutical quality Assurance, R. G, Sapkal College of Pharmacy, Anjaneri, Nashik-422212

Photo
Smita Aher
Co-author

Department of Pharmaceutical Chemistry, R. G, Sapkal College of Pharmacy, Anjaneri, Nashik-422212

Photo
Rishikesh Bachhav
Co-author

Department of Pharmacology, R. G, Sapkal College of Pharmacy, Anjaneri, Nashik-422212

Amol Amrutkar, Smita Aher, Rishikesh Bachhav, A Comprehensive Review On Analytical Method Development And Validation, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 3, 112-124. https://doi.org/10.5281/zenodo.6260581

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