Application of pressurized liquid extraction technology to pharmaceutical solid dosage form analysis.

Area of Science:

• Pharmaceutical Science
• Analytical Chemistry

Background:

• Accurate extraction of active pharmaceutical ingredients (APIs) is crucial for quality control.
• Montelukast sodium is a widely used medication for asthma and allergies.
• Traditional extraction methods can be time-consuming and less efficient.

Purpose of the Study:

• To evaluate pressurized liquid extraction (PLE) for extracting montelukast sodium from oral chewable tablets.
• To optimize PLE parameters including cycles, time, solvent, and temperature.
• To compare the efficiency and precision of PLE with a validated mechanical extraction method.

Main Methods:

• Pressurized liquid extraction (PLE) was employed using montelukast sodium oral chewable tablets as a model.
• Optimization involved varying extraction cycles, duration, solvent composition (water and methanol), and temperature.
• Extraction conditions: 2 cycles of water (2 min, 40°C) for disintegration, followed by 3 cycles of methanol (3 min, 70°C) for solubilization, at 1.0 x 10(4) kPa.

Main Results:

• The optimized PLE method achieved an extraction efficiency of 98.2% of the label claim.
• The relative standard deviation (RSD) for the PLE method was 1.3% (n=10).
• These results were comparable to the validated mechanical extraction method (97.6% efficiency, 0.9% RSD).

Conclusions:

• Pressurized liquid extraction is a highly efficient and precise technique for extracting montelukast sodium from pharmaceutical dosage forms.
• The optimized PLE method provides a reliable alternative to conventional mechanical extraction, potentially reducing analysis time and solvent consumption.
• This study validates PLE as a suitable method for pharmaceutical quality control and analysis of montelukast sodium.