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

Document Type : Original Article

Authors

1 Department of pharmaceutical Chemisty, Faculty of pharmacy, Horus University, 34518, Egypt

2 Pharmaceutical 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

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History

  • Receive Date: 09 September 2022
  • Revise Date: 04 November 2022
  • Accept Date: 16 November 2022

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