RP-HPLC Method Development and Stability-Indicating Assay of Vericiguat: An Analytical Quality by Design and Green Chemistry Approach
1, 1, 1, 1
- 1Department of Quality Assurance, Krupanidhi College of Pharmacy, Bangalore, Karnataka, INDIA.
CORRESPONDENCE
Anjali Nayak
Department of Quality Assurance, Krupanidhi College of Pharmacy, Bangalore, Karnataka, INDIA.
Volume 60, Issue 5 (KrupaPharmaCon 2026) · pp. 274-285 · 2026 · DOI: 10.5530/ijper.krupapharmacon.44
ABSTRACT
Objectives: The present studies describe the systematic development and validation of a stability-indicating and environmentally sustainable RP-HPLC method for the quantification of Vericiguat in bulk form by applying AQbD and green chemistry principles.Materials and Methods: Method optimization was performed by employing custom design, where critical method parameters and critical analytical attributes were evaluated statistically. Optimal chromatographic separation was achieved on a Grace C18 column (250 × 4.6 mm, 5 µm) under isocratic conditions using potassium dihydrogen phosphate buffer and methanol (60:40, v/v, pH 4.5) at a flow rate of 0.75 mL/min, with detection at 254 nm. Method validation and degradation studies conducted according to ICH guidelines. Environmental sustainability was assessed using green analytical assessment tools. Results and Discussion: The optimized method showed a global desirability of 0.75. Vericiguat exhibited a retention time of 3.713 min, plate count of 8253, and tailing factor of 1.53. The method demonstrated excellent linearity over 50-150 µg/mL with an R² value of 0.999. The limit of detection and quantification were 0.082 and 0.20 µg/mL, respectively. Significant degradation was observed under acidic and thermal stress conditions, with degradation of 11.07% and 11.00% within 20% limit. AGREE and MoGAPI scores of 0.79 and 86 confirmed sustainability. The Custom Design approach enabled optimization through contour plots and desirability studies, while validation, stability-indicating, and greenness were established according to ICH guidelines.Conclusion: The developed method is novel, reliable, accurate, environmentally sustainable, and suitable for routine quality control analysis of Vericiguat in bulk drug.
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Vinod, S., Nayak, A., Prakash, S. R., & Govindarajan, S. (2026). RP-HPLC Method Development and Stability-Indicating Assay of Vericiguat: An Analytical Quality by Design and Green Chemistry Approach. Indian Journal of Pharmaceutical Education and Research, 60(5), 274-285. https://doi.org/10.5530/ijper.krupapharmacon.44
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© 2026 Author(s)
This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. CC BY 4.0