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Optimized UHPLC-derivatization method for low-level nitrite detection in pharmaceutical excipients.

Róbert Kormány¹

¹Egis Pharmaceuticals PLC, Keresztúri út 30-38, Budapest H-1106, Hungary.

Journal of Pharmaceutical and Biomedical Analysis

|March 27, 2026

Summary

This study optimized a method for detecting nitrite ions in pharmaceutical excipients using ultra-high-performance liquid chromatography. The validated method achieves high sensitivity and rapid analysis times, crucial for quality control.

Keywords:

Griess-Ilosvay derivatization Nitrite determination Nitrite impurity Sample preparation UHPLC optimization

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Area of Science:

Analytical Chemistry
Pharmaceutical Analysis

Background:

Accurate quantification of nitrite ions is essential for pharmaceutical excipient quality control.
Existing methods may lack the required sensitivity or speed for routine analysis.

Purpose of the Study:

To develop and optimize a rapid and sensitive analytical method for determining nitrite ions in pharmaceutical excipients.
To validate the optimized method using limit tests and assess its performance in real-world samples.

Main Methods:

Nitrite ions were derivatized and subsequently analyzed using ultra-high-performance liquid chromatography (UHPLC) coupled with UV detection.
Method optimization focused on achieving high sensitivity and minimizing analysis time.

Main Results:

The optimized method achieved a detection limit of 1 ng/mL (0.1 ppm) in pharmaceutical excipients.
Analysis time was reduced to less than one minute per sample.
Reproducible recovery rates exceeding 90% were demonstrated.
The method was validated using limit tests, and results from several excipients were presented.

Conclusions:

The developed UHPLC-UV method provides a sensitive, rapid, and reproducible approach for nitrite ion determination in pharmaceutical excipients.
Simple sample preparation and high recovery rates make this method advantageous for pharmaceutical quality control.
The study highlights the impact of sample preparation and storage on analytical results.