ArticleACS omega2025
Implementation of the QbD Approach to the Analytical Method Development and Validation for the Estimation of the Treprostinil Injection Dosage Form by RP-HPLC.
Article in ACS omega, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The trial behind it
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Who cites it
2 citing papers in PubMed.
- Modern Optimization Strategies in High-Performance Liquid Chromatography Analysis.Journal of separation science · 2026Review
- Enhanced Electrochemical Sensing of Treprostinil: A Novel Approach for Sensitive and Selective Detection.ACS omega · 2025Article
Corrections and comments
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Authors and funding
4 authors.
Funding
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Abstract
Quality by design (QbD) is a predictable quality tool that ensures that products meet predefined specifications. QbD involves understanding dependent variables, key factors, and their interactions, assessed through designed experiments analyzing specific responses. The central composite experimental design describes the interrelationships between the flow rate, buffer, and column temperature at different levels, with observed responses including retention time, theoretical plates, and tailing factor analyzed using Design-Expert software. A stability-indicating reverse-phase high-performance chromatography (RP-HPLC) technique was developed and validated for the quantitative estimation of treprostinil, assessing its stability under various forced degradation conditions. Using the optimized method, successful separation of treprostinil was achieved with an Agilent HPLC system with a photodiode array detector and an Express C
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Registered trials
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