[Analysis and stability study on nimotop injections by RP-HPLC]

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis
• Chromatography

Context:

• Nimotop (nimodipine) is a medication used to prevent cerebral vasospasm after subarachnoid hemorrhage.
• Accurate quantification and stability assessment of pharmaceutical formulations are crucial for ensuring drug efficacy and patient safety.
• Existing analytical methods may lack the sensitivity, speed, or specificity required for routine quality control.

Purpose:

• To develop and validate a simple, rapid, and accurate reversed-phase high-performance liquid chromatography (HPLC) method for the analysis of nimotop injections.
• To utilize this method to investigate the stability of nimotop injections under various conditions, specifically temperature and light exposure.
• To establish optimal storage conditions for nimotop injections based on stability data.

Summary:

• A reversed-phase HPLC method was established using a YWG C18 column and a mobile phase of methanol:water (65:35) with methyltestosterone as an internal standard.
• The method demonstrated a linear concentration range of 5.98–299.0 µmol/L and was validated for its simplicity and rapidity.
• Stability studies revealed that nimotop injections are stable at 50°C but degrade when exposed to light, indicating a need for light protection during storage.

Impact:

• The developed HPLC method provides a reliable tool for the quality control and stability testing of nimotop injections in pharmaceutical settings.
• The findings highlight the photosensitivity of nimotop, informing recommendations for proper storage and handling to maintain drug integrity.
• This research contributes to ensuring the therapeutic effectiveness and safety of nimotop by defining its stability profile.