Eco-friendly based method development and validation for Estimation of Vibegron by using UV-Spectrophotometric Method
On December 23, 2020, the US Food and Drug Administration (FDA) authorized Vibegron, also known as GEMTESA, to treat people with overactive bladder (OAB) who exhibit urge urine incontinence, urgency, and frequency of urination. The UV spectrophotometry method is used in this study to determine the drug's dose form in tablets. Additionally, the new method's greenness was assessed. Using methanol as a solvent, the UV technique was created and verified at 249 nm. The new UV spectrophotometric method's ecological impact was evaluated using the greenness assessment tools.For VBG, UV detection reveals linearity between 2.0 and 10.0 μg/mL. The percentage of recovery indicates that there is no interference from the excipients, and the value of % RSD within the limit showed that the procedure is accurate and robust. It was discovered that the analytical method validation parameters matched the acceptance criteria of the ICH Q2(R1) guideline. The method's environmental friendliness in terms of solvent usage, chemical compounds, energy consumption, and waste formation was validated by the results of the greenness evaluation. A trustworthy evaluation of the environmental and health risks connected to chemical use is necessary to determine how green an analytical procedure is.
Authors
- Hitanshi Darji
- Vrushali Ladkat
- Priyanka N imbalkar
- Sanju Mourya
- Rohit Khatmode
- Pravin N.Sable Dr. Pravin N.Sable
Institutions
- Klinik und Poliklinik für Psychosomatik und Psychotherapie (DE)
Publication Details
- Journal
- International Journal of Pharmaceutical Research and Applications
- Published
- 2025-04-01
- DOI
- https://doi.org/10.35629/4494-1004779789
- Primary Topic
- Analytical Chemistry and Sensors
- Type
- article
- Field-Weighted Citation Impact
- 0.00