TRACE-LEVEL QUANTIFICATION OF METHYLP- TOLUENESULFONATE, A GENOTOXIC SULFONATE ESTER IMPURITY, IN PRE GABALIN API AND FINISHED DOSAGE FORMS BY A ROBUST RP-HPLC METHOD
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.
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