Trace-level Quantification of Methylp- Toluenesulfonate, a Genotoxic Sulfonateesterimpurity, in Pregabalin Api and Finisheddosageforms by a Robust Rp-hplc Method
Year: 2026
Type: article
Abstract: A highly sensitive HPLC approach has been developed in the direction of measure the quantity of genotoxicimpurity of methyl p-toluenesulfonate in Pregabalin. The separation was carried out an Intersil column that is ODS- 3V (250 × 4.6 mm, 5 µm) used as the stationary phase. This investigation was accomplished at a temperatureof 25°C by a 20 µL injection volume and 1.0 mL/min flow rate. The Detection of methyl p-toluenesulfonate wasperformed through a UV detector set at 208 nm, and the entire run program for each injection was 40 minutes. Amobile phase containing water and acetonitrile (95:5, v/v) provided effective elution. The method was Validatedaccording to ICH guidelines, and ensuring reliable, accurate results.The separation cores on obtainingwasproceeding(LOQ) limit of quantitation for methyl p-toluenesulfonate was established at 0.31 ppm, indicatingthemethod’s strong sensitivity for trace-level impurity monitoring.
Source: RASAYAN Journal of Chemistry
Institution: Acharya Nagarjuna University
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: diamond
OpenAlex ID: W7127079493