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  Published Paper Details:

  Paper Title

DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS QUANTIFICATION OF DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE AND EPLERENONE IN THEIR SYNTHETIC MIXTURE

  Authors

  Nandini Shah,  Dr. Hitesh Raval,  Hilomi Shah,  Harsh Jani

  Keywords

Dapagliflozin Propanediol Monohydrate (DAPA), Eplerenone (EPLE), First order derivative (D1) UV-Spectrophotometric method, ICH Q2(R2) Guideline

  Abstract


The present research attempts to develop a first order (D1) UV-spectrophotometric method that is convenient to use, robust, cost-effective, quick, and precise for the simultaneous measurement of Dapagliflozin propanediol monohydrate and Eplerenone in their synthetic mixture. The method was validated as per ICHQ2(R2) guidelines. Methanol was utilized as solvent for preparation of sample solution and the detection wavelength to determine DAPA and EPLE in developed fist order UV spectrophotometric method was 240.41 nm and 254 nm respectively. The linearity range for DAPA is 4-12 ?g/ml and EPLE is 10-30 ?g/ml in methanol. The regression coefficient was found to be 0.9988 and 0.9969 for DAPA and EPLE respectively. The LOD and LOQ for DAPA was identified to be 0.4693 and 1.4222 and that for EPLE was 1.314 and 3.983 respectively. Thus, this method provides suitable advantages like improved resolution of overlapping peaks, better selectivity, minimizes background interference. The developed method was successfully applied for the quantification of DAPA and EPLE from their synthetic mixture.

  IJCRT's Publication Details

  Unique Identification Number - IJCRT2512697

  Paper ID - 299237

  Page Number(s) - g228-g234

  Pubished in - Volume 13 | Issue 12 | December 2025

  DOI (Digital Object Identifier) -   

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

  E-ISSN Number - 2320-2882

  Cite this article

  Nandini Shah,  Dr. Hitesh Raval,  Hilomi Shah,  Harsh Jani,   "DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS QUANTIFICATION OF DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE AND EPLERENONE IN THEIR SYNTHETIC MIXTURE", International Journal of Creative Research Thoughts (IJCRT), ISSN:2320-2882, Volume.13, Issue 12, pp.g228-g234, December 2025, Available at :http://www.ijcrt.org/papers/IJCRT2512697.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 and 7.97 Impact Factor Details


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