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INTERNATIONAL JOURNAL OF CREATIVE RESEARCH THOUGHTS - IJCRT (IJCRT.ORG)

International Peer Reviewed & Refereed Journals, Open Access Journal

IJCRT Peer-Reviewed (Refereed) Journal as Per New UGC Rules.

ISSN Approved Journal No: 2320-2882 | Impact factor: 7.97 | ESTD Year: 2013

Call For Paper - Volume 14 | Issue 4 | Month- April 2026

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  Published Paper Details:

  Paper Title

METHOD DEVELOPMENT, VALIDATION AND STRESS DEGRADATION STUDIES OF BULK DRUG AND ITS PHARMACEUTICAL DOSAGE FORM

  Authors

  PAVAN SANJEEV DANGE,  SAMIKSHA NARENDRA AJANKAR,  Dr. Monika P Jadhao,  Ajinkya R Malpe,  Akash C Garudkar

  Keywords

Validation, Stability indicating, Impurity, bioanalytical, HPLC, HPTLC

  Abstract


An essential step in the drug discovery process is the development of analytical methods and subsequent technique validation. Despite the drug's good potency, the lack of a recognised analytical method prevents the drug from being sold. This is to guarantee the standard and the drug's safety. The main goal of this review is to provide information on the traditional and cutting-edge methods used to analyse drugs in both their unprocessed and processed forms, as well as to examine the stability of the drugs in the presence of excipients and other stressors that may occur during the course of their shelf life. The review paper sheds light on hyphenated techniques such LC-MS-MS, LC-NMR-MS, GC-MS, and LC -MS for the analysis and impurity profiling of medicines. The development of bioanalytical methods for the quantitative detection of pharmaceuticals in various biological matrices is also covered in this review. Additionally, it offers a way to assess the medications' biological safety via addressing the SIAMs (stability indicating assay methods).

  IJCRT's Publication Details

  Unique Identification Number - IJCRT2304671

  Paper ID - 232867

  Page Number(s) - f433-f449

  Pubished in - Volume 11 | Issue 4 | April 2023

  DOI (Digital Object Identifier) -   

  Publisher Name - IJCRT | www.ijcrt.org | ISSN : 2320-2882

  E-ISSN Number - 2320-2882

  Cite this article

  PAVAN SANJEEV DANGE,  SAMIKSHA NARENDRA AJANKAR,  Dr. Monika P Jadhao,  Ajinkya R Malpe,  Akash C Garudkar,   "METHOD DEVELOPMENT, VALIDATION AND STRESS DEGRADATION STUDIES OF BULK DRUG AND ITS PHARMACEUTICAL DOSAGE FORM", International Journal of Creative Research Thoughts (IJCRT), ISSN:2320-2882, Volume.11, Issue 4, pp.f433-f449, April 2023, Available at :http://www.ijcrt.org/papers/IJCRT2304671.pdf

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Call For Paper April 2026
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ISSN and 7.97 Impact Factor Details


ISSN
ISSN
ISSN: 2320-2882
Impact Factor: 7.97 and ISSN APPROVED
Journal Starting Year (ESTD) : 2013
ISSN
ISSN and 7.97 Impact Factor Details


ISSN
ISSN
ISSN: 2320-2882
Impact Factor: 7.97 and ISSN APPROVED
Journal Starting Year (ESTD) : 2013
ISSN
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