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INTERNATIONAL JOURNAL OF CREATIVE RESEARCH THOUGHTS - IJCRT (IJCRT.ORG)
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ISSN Approved Journal No: 2320-2882 | Impact factor: 7.97 | ESTD Year: 2013
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Paper Title
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF PROCESS RELATED IMPURITIES FROM LACIDIPINE BULK AND FORMULATION
Authors
Sayali bhagwat arote, Kiran b dhamak, Dr c j bhangale
Keywords
Key-words: Impurity, Lacidipine, Process, HPLC, Validation
Abstract
The process related impurity of Lacidipine 3-{2-[3, 5-bis(ethoxycarbonyl)-1,4-dihydropyridin-4-yl]phenyl}prop-2-enoic acid in bulk and formulations was synthesized, characterized and the RP-HPLC method was developed according to ICH Q2B guidelines for quantitation of impurity in bulk and formulations. The synthesis of intermediate was carried out by Hantzsch pyridine process using substituted aldehyde, EAA and Urea and methanol as catalyst. The percentage yield was found to be 69.89 %. The impurity was recrystallized and purified. The preliminary evaluation was done on lab scale viz. melting point, TLC and elemental analysis. The melting point of impurity was found to be 1560C. The TLC of impurity was carried by using Benzene and Methanol (6:1) and the Rf was found to be 0.80.
IJCRT's Publication Details
Unique Identification Number - IJCRT2108143
Paper ID - 210875
Page Number(s) - b281-b293
Pubished in - Volume 9 | Issue 8 | August 2021
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Publisher Name - IJCRT | www.ijcrt.org | ISSN : 2320-2882
E-ISSN Number - 2320-2882
Cite this article
Sayali bhagwat arote, Kiran b dhamak, Dr c j bhangale, "DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF PROCESS RELATED IMPURITIES FROM LACIDIPINE BULK AND FORMULATION", International Journal of Creative Research Thoughts (IJCRT), ISSN:2320-2882, Volume.9, Issue 8, pp.b281-b293, August 2021, Available at :http://www.ijcrt.org/papers/IJCRT2108143.pdf
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ISSN: 2320-2882 Impact Factor: 7.97 and ISSN APPROVED Journal Starting Year (ESTD) : 2013
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ISSN: 2320-2882 Impact Factor: 7.97 and ISSN APPROVED Journal Starting Year (ESTD) : 2013
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