INTERNATIONAL JOURNAL OF SCIENTIFIC DEVELOPMENT AND RESEARCH International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2455-2631 | Impact factor: 8.15 | ESTD Year: 2016
open access , Peer-reviewed, and Refereed Journals, Impact factor 8.15
Analytical Method Development and Validation by Reverse Phase - High Performance Liquid Chromatography: An Overview
Authors Name:
Dipmala Ghorpade
, Suhas Siddheshwar
Unique Id:
IJSDR2303213
Published In:
Volume 8 Issue 3, March-2023
Abstract:
A simple, precise, accurate, specific and RP-HPLC method was developed for determination of drug in pharmaceutical formulation. Analytical method development and validation play important roles in the drug discovery, drug development and manufacture of pharmaceuticals. It involves detection of the purity and toxicity of a drug substance.The present study focuses on the various steps, parameters involved in HPLC condition.A number of chromatographic parameters were analyzed to optimize the method like sample pretreatment, choosing mobile phase, column, detector selection. Analytical method validation confirms the scientific firmness of measurement or characterization and is necessary throughout the regulatory submission process.Various validation parameters like accuracy, specificity, precision, linearity, LOD, LOQ, ruggedness, and robustness, System suitability also are listed concerning ICH Guidelines.
Keywords:
RP-HPLC, Analytical, Validation, Mobile phase, ICH guidline
Cite Article:
"Analytical Method Development and Validation by Reverse Phase - High Performance Liquid Chromatography: An Overview", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.8, Issue 3, page no.1307 - 1311, March-2023, Available :http://www.ijsdr.org/papers/IJSDR2303213.pdf
Downloads:
000337354
Publication Details:
Published Paper ID: IJSDR2303213
Registration ID:204639
Published In: Volume 8 Issue 3, March-2023
DOI (Digital Object Identifier):
Page No: 1307 - 1311
Publisher: IJSDR | www.ijsdr.org
ISSN Number: 2455-2631
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