World Journal of
Pharmaceutical and Life Sciences

A REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF N-NITROSODIMETHYLAMINE IN CIPROFLOXACIN TABLETS USING GC-MS/MS

Rakam Gopi Krishna*, Srigandham Sadhana, Arunabha Mallik

ABSTRACT

N-Nitrosodimethylamine (NDMA) is a highly potent genotoxic impurity that has raised serious safety and regulatory concerns due to its carcinogenic potential. The discovery of NDMA contamination in various pharmaceutical products has necessitated the development of highly sensitive and selective analytical methods for its detection and quantification. Ciprofloxacin, a widely prescribed fluoroquinolone antibiotic, is considered at risk of nitrosamine contamination owing to its synthetic route, raw materials, and formulation processes. This review provides a comprehensive overview of analytical method development and validation strategies for the determination of NDMA in Ciprofloxacin Tablets USP 750 mg, with a specific focus on gas chromatography–tandem mass spectrometry (GC-MS/MS). The article discusses NDMA chemistry, toxicological significance, regulatory expectations, sources of NDMA formation, analytical challenges, sample preparation techniques, chromatographic and mass spectrometric conditions, and validation parameters in accordance with ICH guidelines. Recent advancements, limitations, and future perspectives in NDMA analysis are also highlighted.

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