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Stability Indicating Method for the Assay of Remogliflozin Etabonate and its Related Substances by RP-HPLC

Stability Indicating Method for the Assay of Remogliflozin Etabonate and its Related Substances... Abstract Simple, accurate, precise and stable indicating HPLC methods were developed and validated to determine both related substances and the assay content of Remogliflozin etabonate (RME). The separation was established under optimized chromatographic condition using Waters e2695 HPLC coupled to Ultraviolet detector (UV) at 228 nm with Inertsil ODS-3V C18 column (250 mm x 4.6 mm, 5 μm), injection volume 10 μl for related substances and 20 μl for assay content determination. The mobile phase consisted of 10 mM KH2PO4 buffer with ortho-phosphoric acid pH 2.5. Gradient elution was maintained at a flow rate of 1.0 ml/min using 45°C column oven temperature for determination of the related substances and isocratic elution was maintained at a flow rate of 1.2 ml/min for assay content. The retention time for RME-01, RME-02, RME-03 and RME-04, RME-05 and RME were about 41.74 min, 11.42 min, 20.38 min, 37.16 min, 49.93 min, 25.05 min respectively. The linearity was found to be in the concentration range of 0.312-2.341 μg/ mL for RME-01, 0.306-2.292 μg/ mL for RME-02, 0.306-2.297 μg/ ml for RME-03 and 0.294-2.203 μg/mL for RME-04. The RME was subjected to acid, base, oxidation, and thermal degradation stress conditions. The method was validated according to the ICH guidelines for specificity, precision, linearity, accuracy and robustness and the values were found to be within the limits. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

Stability Indicating Method for the Assay of Remogliflozin Etabonate and its Related Substances by RP-HPLC

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Publisher
Taylor & Francis
Copyright
© 2023 Har Krishan Bhalla & Sons
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2023.2176785
Publisher site
See Article on Publisher Site

Abstract

Abstract Simple, accurate, precise and stable indicating HPLC methods were developed and validated to determine both related substances and the assay content of Remogliflozin etabonate (RME). The separation was established under optimized chromatographic condition using Waters e2695 HPLC coupled to Ultraviolet detector (UV) at 228 nm with Inertsil ODS-3V C18 column (250 mm x 4.6 mm, 5 μm), injection volume 10 μl for related substances and 20 μl for assay content determination. The mobile phase consisted of 10 mM KH2PO4 buffer with ortho-phosphoric acid pH 2.5. Gradient elution was maintained at a flow rate of 1.0 ml/min using 45°C column oven temperature for determination of the related substances and isocratic elution was maintained at a flow rate of 1.2 ml/min for assay content. The retention time for RME-01, RME-02, RME-03 and RME-04, RME-05 and RME were about 41.74 min, 11.42 min, 20.38 min, 37.16 min, 49.93 min, 25.05 min respectively. The linearity was found to be in the concentration range of 0.312-2.341 μg/ mL for RME-01, 0.306-2.292 μg/ mL for RME-02, 0.306-2.297 μg/ ml for RME-03 and 0.294-2.203 μg/mL for RME-04. The RME was subjected to acid, base, oxidation, and thermal degradation stress conditions. The method was validated according to the ICH guidelines for specificity, precision, linearity, accuracy and robustness and the values were found to be within the limits.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: Jan 2, 2023

Keywords: Remogliflozin Etabonate (RME); related substances; assay; gradient; HPLC

References

  • RME: a novel SGLT2 inhibitor for treatment of diabetes mellitus
  • Remogliflozin etabonate, in a novel category of selective low affinity sodium glucose cotransporter inhibitors, exhibit antidiabetic efficacy in rodent models
  • Assessment of remo-gliflozin etabonate, a sodium-dependent glucose co-transporter-2 inhibitor, as a perpetrator of clinical drug interactions: a study on drug transporters and metabolic enzymes
  • Assessment of the drug interaction risk for remogliflozin etabonate, a sodium-dependent glucose cotransporter-2 inhibitor: evidence from in vitro, human mass balance, and ketoconazole interaction studies
  • Development of ecofriendly derivative spectrophotometric methods for the simultaneous quantitative analysis of Remogliflozin and Vildagliptin from formulation
  • An experimental design approach to quantitative expression for quality control of a multicomponent antidiabetic formulation by the hilic method
  • Development and validation of UV spectroscopic method for determination of remogliflozin etabonate in bulk and tablet dosage form
  • A validated stability indicating high performance thin layer chromatographic method for determination of remogliflozin etabonate in tablet dosage form
  • Stability indicating liquid chromatographic method for the estimation of remogliflozin etabonate
  • Develop-ment and Validation of RP-HPLC and green second derivative UV spectroscopic method for Simultaneous Quantification of Metformin and Remogliflozin in formulation using experimental design