Development and Validation of Comprehensive UV-visible Spectroscopy Method for Sensitive Detection of Nitrite Levels in Pharmaceuticals

ABSTRACT

Introduction: Nitrosamines are known to damage DNA and induce cancer, a characteristic that classifies them as genotoxic and carcinogenic. This research presents an innovative methodology designed for the quantification of nitrite concentrations in active pharmaceutical ingredients, excipients, and finished drug products. This approach mitigates the shortcomings of existing methodologies, which are often characterized by limited sensitivity and elevated costs. Materials and Methods: A novel ultraviolet spectroscopy technique, utilizing the Griess reagent, was developed to facilitate the precise quantification of trace nitrite levels. The method was validated following ICH guidelines, confirming acceptable linearity, sensitivity, accuracy, precision, and robustness. Results: The resulting method offers a cost-effective and easily adaptable solution for the routine monitoring of nitrite in pharmaceutical products, thereby supporting quality control initiatives and ensuring compliance with regulatory standards. The method is validated to meet ICH Q2(R1) and USP<1469> standards, method reliably or accurately exhibited outstanding linearity (r²=0.995-0.999) across a range of concentrations for each API, excipient, and marketed formulation. Notably, this method surpasses traditional approaches by providing a comprehensive tool for quality assurance, which is essential for monitoring nitrosamine formation. Conclusion: The implementation of this method represents a significant advancement in nitrite detection capabilities, providing an essential means for ensuring the safety and quality of pharmaceutical products.

KEYWORDS

• N-Nitrosamines
• Nitrites
• UV-visible spectroscopy
• Method Validation

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• DOI10.5530/ijper.20262950Copy

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