Development and validation of a stability-indicating RP-HPLC method for determination of atomoxetine hydrochloride in...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis
• Chromatography

Background:

• Atomoxetine hydrochloride (ATX) stability is critical for its therapeutic efficacy.
• Forced degradation studies are essential to understand drug stability.
• RP-HPLC is a standard technique for pharmaceutical analysis.

Purpose of the Study:

• To develop and validate a stability-indicating RP-HPLC method for ATX.
• To determine ATX degradation pathways under various stress conditions.
• To ensure accurate quantification of ATX in the presence of degradants.

Main Methods:

• Forced degradation of ATX under acid, base, oxidation, heat, and light.
• Development of a reversed-phase HPLC method using a Phenomenex C18 column.
• Quantification using photodiode array detection at 275 nm.

Main Results:

• ATX degraded under acidic, basic, oxidative, and thermal stress conditions.
• ATX remained stable under photolytic conditions.
• The developed RP-HPLC method successfully separated ATX from its degradation products.
• The method demonstrated high accuracy (100.8 ± 0.4% recovery) and specificity.

Conclusions:

• The developed RP-HPLC method is stability-indicating and suitable for ATX analysis.
• The method provides a reliable tool for quality control and stability assessment of ATX.
• Understanding ATX degradation is vital for formulation development and storage recommendations.