UV Spectrophotometric Method Development and validation of vonoprazan fumarate in Bulk and pharmaceutical Dosage form; Green Profile Evaluation Via eco-scale And GAPI Tools
Ayman Saleh
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