Trimetazidine: stability indicating RPLC assay method

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Trimetazidine hydrochloride is a widely used anti-anginal medication.
• Accurate quantification is crucial for quality control and therapeutic monitoring.
• Existing methods may struggle with specificity in the presence of degradation products.

Purpose of the Study:

• To develop and validate a precise and specific reversed-phase liquid chromatography (RPLC) method.
• To quantify trimetazidine hydrochloride accurately in the presence of its degradation products.
• To apply the method for analyzing trimetazidine hydrochloride in various pharmaceutical formulations.

Main Methods:

• Reversed-phase liquid chromatography using a C-18 column.
• Mobile phase: water-acetonitrile-triethylamine adjusted to pH 3.3 with o-phosphoric acid.
• Detection at 270 nm with a flow rate of 1.0 ml/min.

Main Results:

• Linearity observed in the range of 500-3000 ng (correlation coefficient > 0.998).
• High accuracy with approximately 99-100% recovery.
• Low limits of detection (5 ng) and quantitation (20 ng).

Conclusions:

• The developed RPLC method is accurate, specific, and reproducible.
• It is suitable for the determination of trimetazidine hydrochloride in pharmaceutical formulations, including tablets and controlled-release pellets.
• The method effectively distinguishes the drug from its degradation products.