Specific high-performance liquid chromatographic assay for nitroglycerin in dosage forms

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Nitroglycerin is a critical medication for angina.
• Accurate quantification of nitroglycerin dosage forms is essential for patient safety and therapeutic efficacy.
• Existing analytical methods may lack specificity or efficiency.

Purpose of the Study:

• To develop and validate a specific assay for nitroglycerin dosage forms.
• To enable reliable quantification of nitroglycerin in sublingual tablets.
• To differentiate nitroglycerin from its degradation products.

Main Methods:

• High-performance liquid chromatography (HPLC) was employed.
• Sublingual nitroglycerin tablets were dissolved in water and directly injected.
• Chromatographic conditions included a 60% methanol/water mobile phase, 2 ml/min flow rate, microparticulate reversed-phase column, and 200 nm detection.

Main Results:

• A specific assay for nitroglycerin was successfully developed.
• Glyceryl mononitrate and dinitrate degradation products were effectively separated from nitroglycerin.
• Identification of degradation products was achievable by modifying mobile phase composition.

Conclusions:

• The developed HPLC assay provides a specific and reliable method for nitroglycerin quantification.
• This method allows for the separation and identification of key nitroglycerin degradation products.
• The assay is suitable for routine analysis of nitroglycerin sublingual tablets.