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Updated: Oct 15, 2025
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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
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Solid-State Stability Profiling of Ramipril to Optimize Its Quality Efficiency and Safety
Katarzyna Regulska1, Joanna Musiał2, Beata J Stanisz2
1Greater Poland Cancer Center, 15th Garbary Street, 61-866 Poznan, Poland.
Pharmaceutics
|October 23, 2021
Summary
Ramipril (RAM) degrades rapidly due to heat and humidity, necessitating protective packaging. Excipients offer stability, but tableting and splitting tablets accelerate RAM degradation.
Area of Science:
- Pharmaceutical Sciences
- Drug Stability
- Analytical Chemistry
Background:
- High global spending on expired drugs and safety risks from degradation impurities highlight the need for drug stability profiling.
- Ramipril (RAM) stability is crucial for ensuring therapeutic efficacy and patient safety.
Purpose of the Study:
- To conduct a comprehensive study on the solid-state stability of ramipril (RAM) under various stress conditions.
- To identify factors influencing RAM degradation and characterize the resulting impurities.
Main Methods:
- Utilized isothermal methods and a validated stability-indicating High-Performance Liquid Chromatography (HPLC) protocol.
- Investigated the impact of temperature, relative air humidity (RH), excipients, tablet storage, and packaging on RAM degradation.
- Identified degradation impurities using HPLC-Mass Spectrometry (HPLC-MS).
Main Results:
- Ramipril (RAM) demonstrated instability, with degradation accelerated by increased temperature and relative air humidity (RH).
- Excipients (talc, starch, methylcellulose, hydroxypropyl methylcellulose) stabilized pure RAM, but the tableting process reduced its stability.
- First-order kinetics characterized RAM degradation; identified impurities included ramiprilat and a diketopiperazine derivative.
Conclusions:
- Ramipril (RAM) requires protection from moisture and heat to maintain stability.
- Appropriate immediate packaging, such as blisters, is essential for RAM tablets.
- Tablets should not be crushed to avoid accelerated degradation.
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