Method Development and Validation for Estimation of Vonoprazan By RP-HPLC Method In Bulk and Tablets Dosage Form

Alzaghal, Nader Mohamed; El-Mossalamy, El-Sayed H.; El-Sayed, gamal O.

doi:10.21608/ejchem.2023.193129.7593

	Method Development and Validation for Estimation of Vonoprazan By RP-HPLC Method In Bulk and Tablets Dosage Form
Egyptian Journal of Chemistry
Volume 67, Issue 2, February 2024, Page 145-159 PDF (744.44 K)
Document Type: Review Articles
DOI: 10.21608/ejchem.2023.193129.7593
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Authors
Nader Mohamed Alzaghal ¹; El-Sayed H. El-Mossalamy ²; gamal O. El-Sayed ¹
¹Benha University Faculty of Science Chemistry department
²Benha University faculty of Science Chemistry department
Abstract
Abstract A rapid, simple, and sensitive reversed-phase HPLC-UV method of analysis for Vonoprazan in pharmaceutical formulation. Effective chromatographic separation was achieved using Agilent 5 HC C18 – (150X4.6mm, 5μm) with isocratic elution of the mobile phase consisting of Buffer (0.01M potassium dihydrogen phosphate (1.36 g/L) and 0.02M sodium dihydrogen phosphate (2.4 g/L) in 900ml water, adjust pH 6.8 by 5N sodium hydroxide solution than complete till 1000 ml by water): Acetonitrile (65: 35 v/v). The wavelength of detection was set to be 225 nm (UV detector), and a flow rate of 1.0 ml/min. was employed, 30 μl was used as injection volume and the column temperature was maintained at 35°C. Under these chromatographic conditions, the Peak of Vonoprazan was obtained at a retention time about 3.3 min. and run time of about 6.0 minutes. The developed method was validated according to ICH guidelines for the validation of analytical procedures and was successfully used.
Keywords
Vonoprazan; HPLC; Validation; Forced degradation


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