Spectrophotometric Method Development and Validation of Empagliflozin in Active Pharmaceutical Ingredient and Tablet Dosage Form.

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Title: Spectrophotometric Method Development and Validation of Empagliflozin in Active Pharmaceutical Ingredient and Tablet Dosage Form.
Authors: Sahu, Sagar1 (AUTHOR), Pandey, Ravindra Kumar2 (AUTHOR), Shukla, Shiv Shankar3 (AUTHOR), Gidwani, Bina3 (AUTHOR) beenagidwani@gmail.com
Source: Journal of Applied Spectroscopy. May2024, Vol. 91 Issue 2, p405-410. 6p.
Subjects: Empagliflozin, Simultaneous equations, Hydrochlorothiazide, Detection limit, Standard deviations, Statistical correlation
Abstract: Empagliflozin, an inhibitor of SGLT-2, a sodium glucose co-transporter is found mainly in the proximal tubules of the nephronic components of the kidney. The assay of empagliflozin in its tablet form has been created using a unique, secure, and sensitive UV-spectrophotometric approach. During the development and validation of the method for the assay of empagliflozin, methanol was employed as the solvent. The maximum absorbance wavelength of the solution was determined by scanning in a UV spectrophotometer. At the specified wavelength; absorbance was measured using a variety of calibration standards. The linearity and range of the calibration curve of concentration vs. absorbance were computed. The accuracy, precision, limit of detection, limit of quantitation, and ruggedness of the analytical approach were among the metrics that were determined. A correlation coefficient of 0.999 indicated linearity within the concentration range 2–10 μg/mL. The maximum absorbance of empagliflozin in methanol was determined to be 238.5 nm. Recovery was estimated as per International Conference on Harmonization guidelines and was found to be as per the acceptance limits: 93.25%. The developed UV method was found to be precise with relative standard deviation less than 2%. The assessment of empagliflozin in its tablet formulation using a UV-spectrophotometric technique was determined to be both safe and helpful. The uniqueness of this research is based on a cost-efficient, time-saving, safe, easy, and successful approach for validating empagliflozin. [ABSTRACT FROM AUTHOR]
Copyright of Journal of Applied Spectroscopy is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Label: Title
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  Data: Spectrophotometric Method Development and Validation of Empagliflozin in Active Pharmaceutical Ingredient and Tablet Dosage Form.
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  Data: <searchLink fieldCode="AR" term="%22Sahu%2C+Sagar%22">Sahu, Sagar</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pandey%2C+Ravindra+Kumar%22">Pandey, Ravindra Kumar</searchLink><relatesTo>2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Shukla%2C+Shiv+Shankar%22">Shukla, Shiv Shankar</searchLink><relatesTo>3</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gidwani%2C+Bina%22">Gidwani, Bina</searchLink><relatesTo>3</relatesTo> (AUTHOR)<i> beenagidwani@gmail.com</i>
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  Data: <searchLink fieldCode="JN" term="%22Journal+of+Applied+Spectroscopy%22">Journal of Applied Spectroscopy</searchLink>. May2024, Vol. 91 Issue 2, p405-410. 6p.
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  Data: <searchLink fieldCode="DE" term="%22Empagliflozin%22">Empagliflozin</searchLink><br /><searchLink fieldCode="DE" term="%22Simultaneous+equations%22">Simultaneous equations</searchLink><br /><searchLink fieldCode="DE" term="%22Hydrochlorothiazide%22">Hydrochlorothiazide</searchLink><br /><searchLink fieldCode="DE" term="%22Detection+limit%22">Detection limit</searchLink><br /><searchLink fieldCode="DE" term="%22Standard+deviations%22">Standard deviations</searchLink><br /><searchLink fieldCode="DE" term="%22Statistical+correlation%22">Statistical correlation</searchLink>
– Name: Abstract
  Label: Abstract
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  Data: Empagliflozin, an inhibitor of SGLT-2, a sodium glucose co-transporter is found mainly in the proximal tubules of the nephronic components of the kidney. The assay of empagliflozin in its tablet form has been created using a unique, secure, and sensitive UV-spectrophotometric approach. During the development and validation of the method for the assay of empagliflozin, methanol was employed as the solvent. The maximum absorbance wavelength of the solution was determined by scanning in a UV spectrophotometer. At the specified wavelength; absorbance was measured using a variety of calibration standards. The linearity and range of the calibration curve of concentration vs. absorbance were computed. The accuracy, precision, limit of detection, limit of quantitation, and ruggedness of the analytical approach were among the metrics that were determined. A correlation coefficient of 0.999 indicated linearity within the concentration range 2–10 μg/mL. The maximum absorbance of empagliflozin in methanol was determined to be 238.5 nm. Recovery was estimated as per International Conference on Harmonization guidelines and was found to be as per the acceptance limits: 93.25%. The developed UV method was found to be precise with relative standard deviation less than 2%. The assessment of empagliflozin in its tablet formulation using a UV-spectrophotometric technique was determined to be both safe and helpful. The uniqueness of this research is based on a cost-efficient, time-saving, safe, easy, and successful approach for validating empagliflozin. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
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  Data: <i>Copyright of Journal of Applied Spectroscopy is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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RecordInfo BibRecord:
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      – Type: doi
        Value: 10.1007/s10812-024-01734-8
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      – Code: eng
        Text: English
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        PageCount: 6
        StartPage: 405
    Subjects:
      – SubjectFull: Empagliflozin
        Type: general
      – SubjectFull: Simultaneous equations
        Type: general
      – SubjectFull: Hydrochlorothiazide
        Type: general
      – SubjectFull: Detection limit
        Type: general
      – SubjectFull: Standard deviations
        Type: general
      – SubjectFull: Statistical correlation
        Type: general
    Titles:
      – TitleFull: Spectrophotometric Method Development and Validation of Empagliflozin in Active Pharmaceutical Ingredient and Tablet Dosage Form.
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            NameFull: Sahu, Sagar
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            NameFull: Pandey, Ravindra Kumar
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            NameFull: Shukla, Shiv Shankar
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            NameFull: Gidwani, Bina
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            – D: 01
              M: 05
              Text: May2024
              Type: published
              Y: 2024
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