UV Spectrophotometric Method Development and validation of vonoprazan fumarate in Bulk and pharmaceutical Dosage form; Green Profile Evaluation Via eco-scale And GAPI Tools | ||||
| Egyptian Journal of Chemistry | ||||
| Volume 66, Issue 8, August 2023, Page 141-148 PDF (509.14 K) | ||||
| Document Type: Original Article | ||||
| DOI: 10.21608/ejchem.2022.161704.6948 | ||||
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| Authors | ||||
Ahmed Mohamed Saleh  1; Amira M. El-Kosasy2; Nermine V. Fares2
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| 1Department of pharmaceutical Chemisty, Faculty of pharmacy, Horus University, 34518, Egypt | ||||
| 2Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Abbassia, Cairo 11566, Egypt | ||||
| Abstract | ||||
| A novel, cost-effective, precise, and accurate UV spectrophotometric technique for determining vonoprazan fumarate, a first-in-class potassium-competitive acid blocker, in bulk and tablet medicinal dosage form was developed and validated. Quantitative measurements were taken at 230 nm using methanol and phosphate buffer (50:50 v/v) as a solvent. According to ICH criteria, the parameters of linearity, precision, accuracy, the limit of detection, and the limit of quantitation were investigated. The calibration graph was discovered to be linear over a concentration range of (2-30 g/mL) with a correlation coefficient (r = 0.9998). The proposed method's accuracy was validated using a percentage recovery of 99.48±0.347%, which demonstrated that it was highly accurate. The detection limit was 0.24 g/mL, and the quantification limit was 0.70 g/mL. The results showed that the technique is accurate, precise with relative standard deviation lower than 2%, while also being easy and inexpensive. The proposed method was successfully used to determine the drug in a pharmaceutical formulation without interference from excipients. The research proved that the proposed method can be used in conventional analysis | ||||
| Keywords | ||||
| Vonoprazan Fumarate; Helicobacter pylori; Gastric cancer; proton pump inhibitors; Potassium competitive acid blockers; COVID-19 | ||||
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