Stability-indicating Simultaneous HPTLC Method for Olanzapine and Fluoxetine in Combined Tablet Dosage Form

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis
• Chromatography

Background:

• Olanzapine and fluoxetine are commonly prescribed together for treating mental health conditions.
• Accurate and reliable analytical methods are crucial for quality control of combined dosage forms.
• Stability-indicating methods are essential to ensure drug efficacy and safety throughout shelf life.

Purpose of the Study:

• To develop and validate a rapid, selective, and stability-indicating high-performance thin-layer chromatographic (HP-TLC) method.
• To enable simultaneous estimation of olanzapine and fluoxetine in combined tablet formulations.
• To assess the method's ability to separate the drugs from their degradation products.

Main Methods:

• High-performance thin-layer chromatography (HP-TLC) on silica gel 60 F(254) plates.
• Mobile phase: methanol:toluene (4:2 v/v).
• Spectrodensitometric scanning at 233 nm using Camag TLC Scanner III.

Main Results:

• The method achieved good separation with R(f) values of 0.63 ± 0.01 for olanzapine and 0.31 ± 0.01 for fluoxetine.
• Excellent linearity was observed (r(2) > 0.999) within specified concentration ranges.
• The method demonstrated specificity, with degradation products well-resolved under various stress conditions (acidic, basic, oxidative, thermal, photochemical).

Conclusions:

• The developed HP-TLC method is rapid, selective, and stability-indicating for simultaneous olanzapine and fluoxetine estimation.
• The method's ability to resolve degradation products confirms its suitability for stability studies.
• This validated method can be reliably used for quality control of combined olanzapine and fluoxetine tablet dosage forms.