Semiquantitative Screening of Pharmaceutical Antiviral Drugs using the Agilent 7500ce ICP-MS in Helium Collision Mode

Importance of the Topic

Inorganic impurities in pharmaceuticals can compromise product safety, stability and regulatory compliance. Rapid detection of elemental contaminants enables timely investigation, fingerprinting of unknown samples and prevention of manufacturing failures.

Study Objectives and Overview

This study assesses the feasibility of semiquantitative elemental screening of antiviral drug tablets using an Agilent 7500ce ICP-MS in helium collision mode. The goal is to profile trace metals in multiple production batches and benchmark results against fully quantitative analyses.

Methodology

Sample Preparation:

• Tablets from three batches ground and ~0.06 g digested with HNO₃ and H₂O₂ in a microwave system.
• Digests diluted to 30 g; blanks and Aquacheck QC standards included.

Semiquantitative ICP-MS Screening:

• Single calibration standard (100 ppb of selected elements) updates response factors across the mass range.
• Helium collision cell with kinetic energy discrimination removes polyatomic interferences.
• Acquisition: spectrum-peak hopping, 0.6 s integration, 150 s total time, ~250 masses monitored.
• Internal standardization ensures mass-range coverage; estimated limit of detection ~100 ppt.

Instrumentation

• PerkinElmer Multiwave 3000 microwave digestion system.
• Agilent 7500ce ICP-MS with Octopole Reaction System in He mode.
• Integrated Sample Introduction System (ISIS), MicroMist nebulizer, cooled quartz spray chamber.

Main Results and Discussion

Trace metal profiles from semiquantitative screening matched fully quantitative data across elements including Co, Cr, Cu, Fe, Ni, V and Zn. Full-scan spectra confirmed interference-free isotope ratios. QC recoveries were within ±30 %; sensitivity was comparable to quantitative methods.

Benefits and Practical Applications of the Method

Semiquantitative ICP-MS in He mode offers:

• Rapid screening without full calibration for each element.
• High throughput suitable for quality control and forensic fingerprinting.
• Effective removal of polyatomic interferences in complex matrices.

Future Trends and Applications

Advancements in collision/reaction cell technology may extend screening to diverse dosage forms. Integration with automated workflows and spatially resolved techniques (e.g. LA-ICP-MS) could further enhance contamination mapping and regulatory acceptance.

Conclusion

Semiquantitative elemental screening using He collision ICP-MS demonstrates fast, reliable profiling of trace metals in pharmaceutical tablets. The approach effectively eliminates interferences and aligns with quantitative results, making it a valuable tool in the pharmaceutical manufacturing chain.

Reference

1. J. Roy, Pharmaceutical Impurities – A Mini Review, AAPS PharmSciTech 3(2) article 6.
2. G. Woods, E. McCurdy and S. Wilbur, Interference-Free Semiquantitative Analysis Using the Agilent 7500ce ICP-MS, Agilent Technologies publication 5989-0741EN.
3. M. Oishi and K. Fukuda, Analysis of Electro-ceramics by Laser Ablation ICP-MS, Agilent Technologies publication 5989-0321EN.
4. S. Wilbur, Faster, Simpler, More Accurate Semiquantitative Analysis Using the Agilent 7500cx ICP-MS, Agilent Technologies publication 5989-6662EN.
5. E. McCurdy and G. Woods, J. Anal. At. Spectrom. 19, 607–615 (2004).
6. N. Yamada, J. Takahashi and K. Sakata, J. Anal. At. Spectrom. 17, 1213–1222 (2002).