Nitrosamine Analysis in Sartans

Introduction

Sartan medicines have been the focus of significant recalls because of nitrosamine contamination. Compounds such as NDMA and NDEA can appear in these products if impurities are present in raw materials or if certain reactions take place during synthesis. These nitrosamines are harmful, which is why regulators expect manufacturers to monitor them closely.

Testing sartan tablets for nitrosamines helps confirm that batches remain within acceptable limits and that contamination has not taken place during production. GC-TEA provides the sensitivity needed to measure nitrosamines in complex tablet extracts and has been used widely during investigations into sartan-related recalls.

This method uses gas chromatography with TEA detection to separate and identify a range of nitrosamines associated with sartan manufacturing. It gives laboratories a clear and dependable way to check products before release.

The Challenge

Nitrosamines can appear during sartan synthesis and storage

Several sartan medicines have been recalled because nitrosamines were found in finished tablets. These compounds can form when certain impurities are present in raw materials or when side reactions take place during synthesis. Storage conditions can also influence degradation pathways, which adds another source of variation.

Not every batch is affected. Some tablets may contain measurable nitrosamines while others remain within limits. This variability makes it difficult for manufacturers to confirm whether contamination has taken place until testing is carried out. Because the limits for NDMA, NDEA, and related compounds are low, even small amounts can cause a batch to be held or discarded.

Routine screening helps identify when nitrosamines are present and whether levels fall within acceptable limits. To do this effectively, laboratories need a method that can separate nitrosamines clearly and detect them at low concentrations in complex tablet extracts.

The Solution

GC-TEA gives a clear way to measure nitrosamines in sartan tablets 

Gas chromatography with TEA detection provides the sensitivity and selectivity needed to measure nitrosamines in sartan products. The GC separates each compound in the tablet extract, and the TEA detects the N–NO functional group shared by all nitrosamines. This makes it well suited to NDMA, NDEA, and the wider group of compounds linked to sartan recalls.

Sample preparation is straightforward. A weighed portion of crushed sartan tablets is mixed with methanol to extract any nitrosamines present. The mixture is shaken, filtered through a 0.45 µm PTFE filter, and injected into the GC-TEA. This simple workflow helps maintain consistency and reduces the chance of contamination.

The method provides clear separation across the nitrosamines tested in the study. Chromatograms show distinct peak shapes and stable baselines, even when compounds are present at low concentrations. Calibration curves are linear across the tested ranges, and repeatability remains high when samples are prepared and analysed under the same conditions.

Using GC-TEA allows laboratories to screen sartan batches with confidence. The method highlights tablets that contain measurable nitrosamines and supports decisions about batch quality, storage stability, and further investigation.