Monitoring residual solvents in pharmaceutical products using a portable pre-concentration GC-PID.

Area of Science:

• Analytical Chemistry
• Pharmaceutical Science

Background:

• Residual solvents in pharmaceuticals pose quality control and regulatory challenges.
• Accurate monitoring of these solvents is crucial for patient safety and drug efficacy.

Purpose of the Study:

• To develop a rapid, portable method for analyzing residual solvents in pharmaceutical products.
• To establish a cost-effective quality control solution for drug manufacturing.

Main Methods:

• Utilized a compact-portable gas chromatography with a photoionization detector (GC-PID).
• Employed modified Tedlar® bag sampling and online pre-concentration.
• Integrated miniaturized GC separation and micro-PID detection for direct analysis.

Main Results:

• Achieved low method detection limits (26.00 - 52.03 pg/mL) for residual solvents.
• Demonstrated rapid analysis time (5 min) with high linearity (r² < 0.99) and repeatability (RSD < 0.4%).
• Validated method on over-the-counter drugs showed excellent accuracy (>91.2%) and precision (<6.5% RSD).

Conclusions:

• The developed portable GC-PID method enables fast, accurate, and precise analysis of residual solvents.
• This technique simplifies sample preparation, allowing direct analysis of solid pharmaceutical samples.
• The method is suitable for in-process quality control during pharmaceutical manufacturing.