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
Someshwar Raosaheb Chormale
, S. S. Bhokare , M. S. Charde , R. D. Chakole , Y. U. Dhumale
Unique Id:
IJSDR2306144
Published In:
Volume 8 Issue 6, June-2023
Abstract:
HPLC is the most widely used separation technique for classifying, quantifying, and identifying medicines. A number of chromatographic parameters were changed to enhance the procedure. The mobile stage and sample pretreatment are examined. choosing a column and a detector. The development and validation of analytical methods are crucial for the development and discovery of new drugs. The numerous steps necessary in creating and establishing the validity of an HPLC technology are covered in this paper. The chemistry of the molecules, the synthetic route, solubility, polarity, pH and pKa values, and the activity of functional groups are a few more elements that affect the development of an HPLC technique. According to ICH Guidelines, validating an HPLC process includes testing for accuracy, specificity, linearity, range, limit of detection, limit of quantification, robustness, and system suitability.
Keywords:
High-Pressure Liquid Chromatography (HPLC), Method validation, Method development
Cite Article:
"Development of Validated method by HPLC: A Review", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.8, Issue 6, page no.1007 - 1013, June-2023, Available :http://www.ijsdr.org/papers/IJSDR2306144.pdf
Downloads:
000337352
Publication Details:
Published Paper ID: IJSDR2306144
Registration ID:207244
Published In: Volume 8 Issue 6, June-2023
DOI (Digital Object Identifier):
Page No: 1007 - 1013
Publisher: IJSDR | www.ijsdr.org
ISSN Number: 2455-2631
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