Analysis of Ibuprofen and Its Related Substance

Význam tématu

Ibuprofen is one of the most commonly used non-steroidal anti-inflammatory drugs (NSAIDs). Accurate quantification of ibuprofen along with its related substances is crucial for ensuring drug safety, regulatory compliance and consistent product quality in pharmaceutical manufacturing.

Cíle a přehled studie / článku

The objective of this application note is to present a rapid and robust reversed-phase liquid chromatography method for simultaneous determination of ibuprofen and two related impurities: valerophenone and 4-isobutylacetophenone. The study demonstrates method performance using Shimadzu UFPLC instrumentation and Shim-pack VP-ODS column technology.

Použitá instrumentace

• HPLC system: Shimadzu Prominence UFPLC
• Column: Shim-pack VP-ODS, 250 mm × 4.6 mm I.D., 5 μm particle size
• Detector: UV absorbance at 230 nm (analytical cell)
• Injection volume: 10 μL

Použitá metodika

The mobile phase consisted of 1% (w/v) chloroacetic acid aqueous solution (pH adjusted to 3.0 with ammonium hydroxide) as phase A and acetonitrile as phase B (A/B = 2/3 v/v). Chromatographic conditions were set at 2.0 mL/min flow rate, column temperature 30 °C. Under these conditions, separation of the three analytes was achieved in under 8 minutes.

Hlavní výsledky a diskuse

• Baseline separation of ibuprofen, valerophenone and 4-isobutylacetophenone was achieved with resolution greater than 2.0.
• Typical retention times were approximately 3.0 min for ibuprofen, 4.8 min for valerophenone and 6.5 min for 4-isobutylacetophenone.
• All compounds showed sharp peak shapes and linear detector response at the tested concentration (500 mg/L each).

These results confirm the method’s suitability for routine quality control analyses.

Přínosy a praktické využití metody

This fast and reliable HPLC method can be directly employed in pharmaceutical QC laboratories for batch release testing, impurity profiling and stability studies. The short run time and simple mobile phase composition enhance throughput and reduce solvent consumption.

Budoucí trendy a možnosti využití

• Coupling with mass spectrometry for enhanced specificity and lower detection limits.
• Adapting to UHPLC formats for further reduction in analysis time and eluent usage.
• Exploration of greener solvents and buffer systems to minimize environmental impact.
• Integration into automated workflows and process analytical technology (PAT) for real-time monitoring.

Závěr

The presented reversed-phase LC method using Shim-pack VP-ODS column and Shimadzu UFPLC platform provides a robust, rapid and reproducible approach for simultaneous analysis of ibuprofen and its related substances. Its simplicity and performance make it well suited for routine pharmaceutical quality control.

Reference

Shimadzu Corporation. Application News L526, Analysis of Ibuprofen and Its Related Substance, ERAS-1000-0124, First Edition: December 2021.