Simple and Fast Stability Indicating UPLC Method for the Simultaneous Quantification of Vildagliptin and Remogliflozin Etabonate in Bulk Drug and Formulations

Authors

  • Syed Mastan Ali Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar (PO)- 522 510.
  • Ponnuri Bharath Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar (PO)- 522 510.
  • Syed Khasim Sharif Department of Chemistry, Dr. SRK Govt Art’s College, Pondicherry Central University,Yanam- 533 464.
  • D Ramachandran Department of Chemistry, Dr. SRK Govt Art’s College, Pondicherry Central University,Yanam- 533 464.

DOI:

https://doi.org/10.5530/ctbp.2021.4.41

Keywords:

Vildagliptin, Remogliflozin, UPLC method development, Method Validation, Forced degradation study, Formulation assay

Abstract

This study reports for the first time about a stability indicating RP-UPLC method for separation and simultaneous of vildagliptin and remogliflozin etabonate. The separation was achieved on Acquity® UPLC BEH C18 (2.1 × 50 mm, 1.7 μm) column as stationary phase, 0.1 M acetate buffer at pH 5.7 and methanol in the ratio of 25:75 (v/v) at 0.3 mL/min flow rate and PDA detector at 215 nm. In these conditions, the resolution of the compounds was obtained as 12.57 with retention time of 2.67 min for remogliflozin and 3.84 min for vildagliptin. The method was validated for system suitability, range of analysis, precision, specificity, stability and robustness. Forced degradation study was done through exposure of the analytes to five different stress conditions and in all the degradation condition, the % degradation was very less, and the method can separate and estimate the vildagliptin and remogliflozin in pharmaceutical formulations. Hence the developed method was found to be suitable for the separation and simultaneous quantification of vildagliptin and remogliflozin in bulk drug and pharmaceutical formulations.

UPLC chromatograms observed in the optimized conditions. A): Blank solution; B): Standard solution containing vildagliptin and remogliflozin

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Published

2021-12-23

How to Cite

Ali, S. M. ., Bharath, P. ., Sharif, S. K., & Ramachandran, D. (2021). Simple and Fast Stability Indicating UPLC Method for the Simultaneous Quantification of Vildagliptin and Remogliflozin Etabonate in Bulk Drug and Formulations. Current Trends in Biotechnology and Pharmacy, 15(4), 401–407. https://doi.org/10.5530/ctbp.2021.4.41