INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016
Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI)
A new, precise, rapid and accurate UV Spectrophotometric and RP-HPLC method was developed for the Simultaneous Estimation of Gemigliptin and Dapagliflozin in synthetic mixture. Simultaneous equation UV method was performed on Shimadzu UV-1700 Spectrophotometer based on measurement of Gemigliptin and Dapagliflozin absorption in methanol at 248.40 nm and 224 nm, respectively, over 20-60 μg/ml and 4-12 μg/ml linear ranges. RP-HPLC method was designed using an HPLC system-equipped PDA detector. After optimization of good chromatographic separation was achieved with a mixture of Acetonitrile : Methanol : Ammonium acetate buffer (pH-5.5) in the volume ratio of 60:20:20 %v/v/v as the mobile phase with , C18 column (250 mm × 4.6 mm, 5 µm) as stationary phase at flow rate of 1 ml/min and detection wavelength of 268 nm. The retention time of Gemigliptin and Dapagliflozin was found to be 4.403 min and 8.328 min respectively. The linearity of this method was found in the concentration range of 50 to 250 μg/ml for Gemigliptin and 10 to 50 μg/ml for Dapagliflozin. The correlation coefficient r2 value was found to be 0.9992 for Gemigliptin and 0.9999 for Dapagliflozin. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuracy, Precision, specificity and Robustness.
Keywords:
UV Spectroscopy, RP-HPLC, Method Development and Validation, Validation Parameters
Cite Article:
"Development and Validation of Analytical Method for Simultaneous Estimation of Gemigliptin and Dapagliflozin in Synthetic Mixture", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.8, Issue 5, page no.f171-f186, May-2023, Available :http://www.ijnrd.org/papers/IJNRD2305537.pdf
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ISSN:
2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
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