Trace-level quantification of NDMA in levosulpuride active pharmaceutical ingredient and tablet formulation Using UFLC-MS/MS

Hemanth Vikram, P․R. and Gunjan, Kumar and Rajashree, Deka and Umme, Hani and Nazima, Haider and Sirajunisa, Talath and Adil Farooq, Wali and Dilipkumar Reddy, Kandula and Narasimha M., Beeraka. and Sinchana B., Gopalaiah and Devi Sri, Chiriki and Namitha, Bannimath and Pramod, Kumar and Bannimath, Gurupadayya (2024) Trace-level quantification of NDMA in levosulpuride active pharmaceutical ingredient and tablet formulation Using UFLC-MS/MS. Talanta Open, 10. ISSN 26668319

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Abstract

Nitrosamine impurities identified in several pharmaceuticals during recent times has raised concerns leading to product recalls worldwide and necessitating sensitive liquid and gas chromatographic methods for trace level detection of nitrosamine impurities. This study developed and validated a ultra-fast liquid chromatography-tandem mass spectrometry (UFLC-MS/MS) method for the quantification of NDMA in Levosulpuride drug substance and tablet formulation. Current method utilizes a triple quadrupole analyzer, atmospheric pressure chemical ionization (APCI) ionization source and multiple reaction monitoring (MRM) scan mode for the analysis. Chromatographic separation was achieved on a Gemini NX-C18 column (150 × 4.6 mm, 3 µm) maintained at 40 °C. The mobile phase consisted of a binary gradient of solvent A (0.1 % formic acid in water) and solvent B (methanol), with a total run time of 18 minutes. Current method achieved excellent linearity, recovery, precision, and sensitivity. Greenness of the developed method was evaluated using the GAPI, AGREE, and AES metrics. Current method is sensitive and selective for NDMA in levosulpuride drug substance and tablet formulations and can be employed for routine quality control analysis in pharmaceutical industry.

Item Type:	Article
Uncontrolled Keywords:	Genotoxic; Greenness assessment; Levosulpuride; NDMA; Nitrosamine impurities
Subjects:	C Chemical Science > Chemistry
Divisions:	Department of > Chemistry
Depositing User:	Mr Eranna Library
Date Deposited:	29 Nov 2025 11:14
Last Modified:	29 Nov 2025 11:14
URI:	http://eprints.uni-mysore.ac.in/id/eprint/18107

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