Unspecified degradation impurities identification and characterization in bilastine and montelukast tablet formulations by using UPLC and LCMS/MS: Robustness by design expert and green assessment
The UPLC-based analytical method demonstrated in this study is an effective and efficient technique for the quantification of BLS, MTK, and their associated impurities in tablet formulations. This method has been validated in accordance with ICH Q2(R2) and USP <1225> guidelines.
Authors
- T. Mondal (ORCID: https://orcid.org/0000-0002-3060-795X)
- Sreedhar Gundekari (ORCID: https://orcid.org/0000-0002-5891-058X)
- Mohan Varkolu (ORCID: https://orcid.org/0000-0002-8488-555X)
- Naresh Konduru (ORCID: https://orcid.org/0000-0003-0815-9238)
- Leela Prasad Kowtharapu (ORCID: https://orcid.org/0000-0003-1199-2458)
- Kousrali Sayyad (ORCID: https://orcid.org/0000-0002-7057-2608)
- Raj Kumar Kodishala (ORCID: https://orcid.org/0009-0003-1101-0888)
Institutions
- Koneru Lakshmaiah Education Foundation (IN)
- GITAM University (IN)
Publication Details
- Journal
- Annales Pharmaceutiques Françaises
- Published
- 2025-04-26
- DOI
- https://doi.org/10.1016/j.pharma.2025.04.006
- Citations
- 4
- Primary Topic
- Analytical Methods in Pharmaceuticals
- Type
- article
- Field-Weighted Citation Impact
- 3.01