Improved Chromatographic Analysis of Non- Steroidal Anti-Inflammatory Drugs (NSAIDs) Using CORTECS™ Premier Columns That Feature MaxPeak™ High Performance Surfaces HPS Technology

Significance of the Topic

Non‐steroidal anti‐inflammatory drugs (NSAIDs) are among the most widely used over‐the‐counter medications worldwide. Reliable, rapid chromatographic methods are essential to ensure product quality, safety, and regulatory compliance throughout pharmaceutical manufacturing and quality control laboratories.

Objectives and Study Overview

The primary aim of this study was to develop and validate a fast, reproducible method for separating and quantifying common NSAIDs using CORTECS Premier Columns with MaxPeak™ High Performance Surfaces (HPS) technology. A secondary goal was to compare performance metrics against traditional stainless‐steel UPLC systems and evaluate column lot‐to‐lot consistency.

Methodology and Instrumentation

Sample Preparation:

• Individual stock solutions of fenoprofen, diclofenac, naproxen, and ibuprofen prepared at 1 mg/mL in methanol.
• Mixed standard at 50 µg/mL (fenoprofen, diclofenac, naproxen) and 500 µg/mL ibuprofen.
• Diclofenac calibration range prepared from 5 µg/mL to 500 µg/mL.

LC Conditions:

• Mobile phase gradient optimized for sub‐2-minute separation.
• Detection at 270 nm using photodiode array detector.

Instrumentation

• ACQUITY Premier™ LC System with CORTECS Premier C18 Column (MaxPeak HPS technology).
• ACQUITY UPLC I-Class LC System with CORTECS C18 Column (stainless-steel hardware).
• 2998 Photodiode Array Detector and Empower 3 Software (Build 3471).

Main Results and Discussion

Reproducibility:

• Ten replicate injections yielded <5% RSD for peak area and retention time across all analytes.

Linearity:

• Diclofenac calibration from 5 µg/mL to 500 µg/mL achieved R² > 0.999, demonstrating suitability for quantitative QC testing.

System Comparison:

• CSP HPS columns showed up to 25% reduction in peak tailing and 39% increase in signal height versus stainless‐steel systems.
• Both configurations provided baseline separation within two minutes; however, HPS technology minimized metal‐analyte interactions that often degrade peak shape in acidic mobile phases.

Lot‐to‐Lot Reproducibility:

• Three independent lots of CORTECS Premier columns produced consistent retention times (<2% RSD), confirming reliable manufacturing performance.

Benefits and Practical Applications

• Rapid analysis (<2 minutes) increases sample throughput in high-volume QC laboratories.
• Enhanced peak shape and sensitivity improve detection limits and quantitation accuracy.
• Reduced metal‐surface interactions extend column life and lower maintenance costs when using acidic or chloride‐containing mobile phases.

Future Trends and Applications

The success of HPS technology in NSAID analysis suggests broader applications for other acidic or metal‐sensitive compounds. Future developments may include:

• Extension to LC–MS workflows for trace‐level impurity profiling.
• Customized stationary phases to further reduce nonspecific adsorption.
• Integration with automated sampling to support real‐time release testing in pharmaceutical production.

Conclusion

CORTECS Premier Columns with MaxPeak HPS technology provide a robust, fast, and reproducible platform for NSAID analysis. Compared to traditional stainless-steel systems, the new technology substantially improves peak shape, sensitivity, and batch‐to‐batch consistency, making it highly suitable for stringent quality control environments.

Reference

1. Gaikwad N, Vaishnavi P, Dhaneria S. Assessment of Nonsteroidal Anti‐inflammatory Drug Use Pattern Using WHO Indicators: A Cross‐Sectional Study. Indian J Pharmacol. 2017;49(6):445.
2. U.S. Food and Drug Administration. Nonsteroidal Anti‐inflammatory Drugs (NSAIDs). FDA; 2020.
3. Walter T, et al. Low Adsorption UPLC Systems and Columns Based on MaxPeak HPS. Waters White Paper 720007128.
4. Layton C, Rainville P. Improvements in Chromatographic Performance for Antiviral Drugs with MaxPeak Premier Technology. Waters App. Note 720007487; 2022.
5. Shah D, et al. Analysis of Fourteen Organic Acids in Beverages Using UPLC and QDa Detector. Waters App. Note 720007289; 2021.
6. Waters Corp. CORTECS Columns. Waters Applications Notebook 720004739; 2012.