Microwave-assisted extraction of active pharmaceutical ingredient from solid dosage forms.

Area of Science:

• Pharmaceutical Analysis
• Analytical Chemistry
• Process Chemistry

Background:

• Traditional extraction methods for pharmaceutical analysis can be time-consuming and less efficient.
• Optimizing extraction techniques is crucial for accurate API quantification in solid dosage forms.

Purpose of the Study:

• To evaluate the efficacy of Microwave Assisted Extraction (MAE) for extracting Active Pharmaceutical Ingredients (APIs) from solid dosage forms.
• To optimize MAE parameters for efficient API recovery and to demonstrate its applicability in routine pharmaceutical testing.

Main Methods:

• Microwave Assisted Extraction (MAE) was optimized for solvent composition, time, and temperature using Compound A tablets.
• The optimized MAE method was validated for content uniformity and potency assays.
• MAE was applied to extract montelukast sodium from various solid dosage forms.

Main Results:

• Complete recovery of Compound A was achieved using acetonitrile at 50°C for 5 min.
• MAE demonstrated high extraction efficiency (97.4-101.9%) for montelukast sodium, with low variability (RSD ≤ 1.4%).
• MAE results compared favorably with validated mechanical extraction procedures.

Conclusions:

• MAE is a rapid, efficient, and user-friendly technique for API extraction from solid dosage forms.
• The MAE method offers high throughput and can significantly reduce cycle times, enhancing laboratory productivity.
• MAE provides a cost-effective and reliable alternative to traditional extraction methods in pharmaceutical quality control.