Development and validation of a QbD-based RP-HPLC method for vericiguat quantification
DOI:
https://doi.org/10.18231/j.joapr.2024.12.2.57.67Keywords:
Quality by Design (QbD), RP High Performance Liquid Chromatography (RP-HPLC), Vericiguat, Central Composite Design (CCD)Abstract
Aim: An RP-HPLC method for Vericiguat using the QbD approach was developed and validated by ICH guidelines. Method: The ICH (Q2R1) guidelines have been followed in the development and validation of an RP-HPLC technique by considering several validation parameters like linearity, precision, LOD, LOQ, and accuracy. The study was performed on Agilent Tech using the C18 column (4.6x250 mm; 5 µm) and Chemstation 10.1 software with statistical data analysis, and the detector used was UV (DAD). Results: The mobile phase used for separation was Methanol: 0.1% OPA in the ratio of (76:24) at room temperature, the flow rate was 0.8ml/min, and the wavelength was 331nm. The results indicated that the quantification limit was 0.7209 µg/ml, and the detection limit was 0.2379 µg/ml. Conclusion: The validation studies confirmed that the developed method is fast, accurate, precise, cost-effective, selective, and useful for routine analysis of vericiguat in tablet dosage forms.
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Copyright (c) 2024 Shubham Mandhare, Rahul Godge, Akshay Vikhe, Shubham Talole
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