Analytical Method Development and Validation: A Review
Author(s):
Nikita Kumawat, Singh Hamendra Pratap, Goyal Anju
Keywords:
Chromatography method, Error, Precision, Spectrophotometric, Validation.
Abstract
The main objective of analytical method development and validation are the incessant and inter-reliant task related with the research and expansion in quality control & quality assurance departments. Analytical methods play a critical role in manufacturing of pharmaceuticals and evaluation of medicines in pharmaceutical formulation and it also helps in establishment of product-specific acceptance criteria and constancy of results. In pharmaceutical industries, validation process is very essential for the effective running of pharmaceutical firms which includes performance of validation, types of validation and validation policy are comply with the requirements of Good Manufacture Practice (GMP) regulations. A novel, safe and susceptible methods like UV-Visible spectrophotometric, HPLC and Chromatography methods has been discussed in this article. A method will be developed which will give information about validation parameters like accuracy, precision, linearity, LOD, LOQ, specificity, range, robustness, ruggedness, repeatability and reproducibility. Validation provides major improvements in precision and a reduction in errors. It can further help to avoid expenses and time consuming exercises.
Article Details
Unique Paper ID: 159522

Publication Volume & Issue: Volume 9, Issue 12

Page(s): 74 - 84
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