Journal of Applied Pharmaceutical Research
Vol. 12 No. 2 (2024)

Development and validation of a QbD-based RP-HPLC method for vericiguat quantification

Mandhare, Shubham (Unknown)
Godge, Rahul (Unknown)
Vikhe, Akshay (Unknown)
Talole, Shubham (Unknown)



Article Info

Publish Date
30 Apr 2024

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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Journal Info

Abbrev

joapr

Publisher

Subject

Medicine & Pharmacology

Description

Journal of Applied Pharmaceutical Research (JOAPR) is an official publication of Creative Pharma Assent (CPA). It is an open access, peer review online international journal. JOAPR is primarily focused on multiple discipline of pharmaceutical sciences (Pharmaceutics, Pharmaceutical Technology, ...