1*Research Guide, Department of Pharmaceutical Chemistry, PDEA's, Shankarrao Ursal College of Pharmaceutical Sciences & Research Center, affiliated to Savitribai Phule Pune University, Kharadi, Pune - 411014
2Research Scholar, Department of Pharmaceutical Chemistry, PDEA's, Shankarrao Ursal College of Pharmaceutical Sciences & Research Center, affiliated to Savitribai Phule Pune University, Kharadi, Pune - 411014
Received: 12th Dec, 2025; Revised: 12th Feb 2026; Accepted: 13th Feb, 2026; Available Online: 10th March, 2026
Molnupiravir is an antiviral drug used to treat moderate-to-severe Coronavirus Disease-2019 (COVID-19) infection. The current research article presents a novel method that applies the principle of quality by design (QbD) to the development of a robust High Performance Liquid Chromatography (HPLC) method for estimating Molnupiravir in Active Pharmaceutical Ingredient (API) and its capsule formulation. Using this QbD concept, we have defined the Quality Target Method Profile (QTMP), identified Critical Quality Attributes (CQA), including Critical Analytical Attributes (CAA), Critical Material Attributes (CMA), and applied risk assessment to optimize CMA. Through Central Composite Design (CCD), a design space was obtained, ensuring the robustness of the proposed method. Mobile phase of the developed method was optimized to 80:20 ratio for Water: ACN (Acetonitrile) with flow rate of 1.0 ml/min, measured at 235 nm wavelength. The chromatographic run time of the proposed analytical method is 10 minutes. The optimized HPLC method was validated as per the International Council of Harmonisation (ICH) Q2 (R1) guidelines. The study highlights the effectiveness of QbD strategy in achieving a reliable and optimized liquid chromatographic method for Molnupiravir quantification.
Keywords: Robust, Central Composite Design, ICH (Q2) R1
How to cite this article: Barge VU, Bhalerao RA. Development of QbD Driven Liquid Chromatographic Method for Quantification of Molnupiravir API Capsule Formulation. Int J Drug Deliv Technol. 2026;16(3): 679. DOI: 10.25258/ijddt.16.3.75
Source of support: Nil.
Conflict of interest: None