High‐Sensitivity LC‐MS/MS Method for Precise Quantification of N‐Nitroso Sertraline in the Antidepressant Sertraline Drug Products DOI

Kiran Kumar Chagarlamudi,

Rajesh Damarapurapu,

Venkata Siva Suryanarayana Gurram

et al.

Separation Science Plus, Journal Year: 2025, Volume and Issue: 8(5)

Published: May 1, 2025

ABSTRACT The presence of N‐nitrosamine impurities in medications has prompted serious regulatory concerns since they may cause cancer. N‐Nitroso Sertraline is one the that can develop during production and storage sertraline medicinal products, it considered to be a significant impurity. Chromatographic separation was achieved by using Waters XBridge C 8, 4.6×150 mm, 3.5 µm. gradient elution technique employed for mobile phase, comprising Phase A, solution 0.1% formic acid water, B, methanol with flow rate 0.8 mL/min. This work introduces liquid chromatography‐tandem mass spectrometry (LC‐MS/MS) approach extremely sensitive selective accurately measuring amount pharmaceutical formulations. showed high degree linearity across concentration range LOQ‐150%, correlation coefficient ( R 2 ) greater than 0.99. limit detection (LOD) quantification (LOQ) were determined 0.03% 0.05%, which allows identification at trace levels. A linear response >0.999), accuracy (recoveries 95.3%–101.9%), precision (RS ≤ 2.0%), sensitivity, specificity demonstrated proposed method. successfully used on commercial medication items, detecting levels are within limits. established LC‐MS/MS method valuable resource routine quality control impurity analysis formulations due its superior linearity, precision, accuracy, lower limits compared other methods.

Language: Английский

High‐Sensitivity LC‐MS/MS Method for Precise Quantification of N‐Nitroso Sertraline in the Antidepressant Sertraline Drug Products DOI

Kiran Kumar Chagarlamudi,

Rajesh Damarapurapu,

Venkata Siva Suryanarayana Gurram

et al.

Separation Science Plus, Journal Year: 2025, Volume and Issue: 8(5)

Published: May 1, 2025

ABSTRACT The presence of N‐nitrosamine impurities in medications has prompted serious regulatory concerns since they may cause cancer. N‐Nitroso Sertraline is one the that can develop during production and storage sertraline medicinal products, it considered to be a significant impurity. Chromatographic separation was achieved by using Waters XBridge C 8, 4.6×150 mm, 3.5 µm. gradient elution technique employed for mobile phase, comprising Phase A, solution 0.1% formic acid water, B, methanol with flow rate 0.8 mL/min. This work introduces liquid chromatography‐tandem mass spectrometry (LC‐MS/MS) approach extremely sensitive selective accurately measuring amount pharmaceutical formulations. showed high degree linearity across concentration range LOQ‐150%, correlation coefficient ( R 2 ) greater than 0.99. limit detection (LOD) quantification (LOQ) were determined 0.03% 0.05%, which allows identification at trace levels. A linear response >0.999), accuracy (recoveries 95.3%–101.9%), precision (RS ≤ 2.0%), sensitivity, specificity demonstrated proposed method. successfully used on commercial medication items, detecting levels are within limits. established LC‐MS/MS method valuable resource routine quality control impurity analysis formulations due its superior linearity, precision, accuracy, lower limits compared other methods.

Language: Английский

Citations

0