LC-MS/MS Analytical Method Development and Validation for Determining Vinamidinium HexafluoroPhosphate Impurity in Etoricoxib
1, 1, 2, 1
- 1Department of Chemistry, Andhra University, Visakhapatnam, Andhra Pradesh, INDIA.
- 2Department of Quality Control, Aurobindo Pharma Limited, Hyderabad, Telangana, INDIA.
CORRESPONDENCE
Prof. T. Siva Rao
Department of Chemistry, Andhra University, Visakhapatnam, Andhra Pradesh, INDIA.
Received: 15-12-2022; Accepted: 16-04-2023.
Volume 57, Issue 3 · pp. 883-889 · 2023 · DOI: 10.5530/ijper.57.3.106
ABSTRACT
Background and Aim: Process impurities may adversely affect the efficacy, excellent quality, and safety of pharmaceutical drugs. Ultimately, the purpose of this research work was to develop and validate a LC-MS/MS-based method for determining the Vinamidinium hexafluorophosphate impurity (VHP) in Etoricoxib in a simple, specific, accurate, and precise manner.Materials and Methods: To elute the Vinamidinium hexafluorophosphate impurity in Etoricoxib at a flow rate of 0.5mL/min within 20.0 min of runtime, a Symmetry Shield RP18, 5µm column with a 150 x 3.9 mm internal diameter was utilized in binary gradient mode. The buffer solution, which contained formic acid (0.1%) and acetonitrile (100%), as well as a diluent solution of acetonitrile (50%) and water (50%), was used to achieve the chromatographic separation. A triple quadrupole mass spectrometer (Shimadzu LC/MS/MS 8040) in Multiple Reaction Monitoring (MRM) mode was needed to monitor the results. Results and Discussion: The method's linearity was evaluated at levels from 25% to 150%, and the R2 value was discovered to be 0.99. Sensitivity values of 0.04µg/g (LOD) and 0.13µg/g (LOQ) were established. The recovery of impurity levels of Vinamidinium hexafluorophosphate ranges from 70.0% to 130%. Linearity, specificity, accuracy, LOD, LOQ, and precision of the method were all validated. Within the assay variability limitations, it was found that the intra- and inter-day precision values were 0.67%, and 0.58%, respectively.Conclusion: According to ICH and FDA specifications, the optimized method was validated. The developed method was found to be appropriate for quantifying Vinamidinium hexafluorophosphate in Etoricoxib by employing LC-MS.
KEYWORDS
REFERENCES
As publishedShowing references and in-text citations exactly as published.
Cite this article
SELECT FORMAT
Ganta, S., Rao, T. S., Srinivas, K. R., & Suman, P. (2023). LC-MS/MS Analytical Method Development and Validation for Determining Vinamidinium HexafluoroPhosphate Impurity in Etoricoxib. Indian Journal of Pharmaceutical Education and Research, 57(3), 883-889. https://doi.org/10.5530/ijper.57.3.106
Copyright and licence
© 2023 Author(s)
This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. CC BY 4.0