Stability indicating LC method for the determination of pipamperone

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Pipamperone analysis requires methods capable of separating it from related impurities and degradation products.
• Ensuring drug quality necessitates robust analytical techniques for stability assessment.

Purpose of the Study:

• To develop and validate a high-performance liquid chromatographic (HPLC) method for pipamperone determination.
• To assess the stability of pipamperone under various conditions using the developed HPLC method.

Main Methods:

• High-performance liquid chromatography (HPLC) utilizing an amide functionalized bonded phase column (LC-ABZ+ Plus).
• A specific mobile phase composition: acetonitrile-tetrahydrofuran-sodium phosphate monobasic (0.05 M, pH 6.5) (16:11:73, v/v/v).
• Analysis of pipamperone in the presence of a related impurity and degradation products with rapid elution (<8 min).

Main Results:

• The developed HPLC method demonstrated high precision, accuracy, and specificity.
• Pipamperone stability was confirmed in acidic conditions.
• Degradation of pipamperone was observed under basic and oxidative conditions.

Conclusions:

• The proposed HPLC method is suitable for the accurate and precise determination of pipamperone.
• The method can be effectively employed in stability assays to evaluate pipamperone's integrity over time.