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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), ICH Q2(R2): Validation of Analytical Procedures, ICH Harmonised Guideline, Final Version, adopted 1 November 2023.

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Article

Rapid and Sensitive LCMS/MS Method for the Detection and Quantitation of Nitrosamine Drug Substance Related Impurity in Antihypertensive Drug Lercanidipine

1Pharmaceutical Analysis and Quality assurance division, Andhra University College of pharmaceutical sciences, Andhra University, Visakhapatnam, India

2College of Science and Technology, Andhra University, Visakhapatnam, India


World Journal of Analytical Chemistry. 2026, Vol. 11 No. 1, 15-19
DOI: 10.12691/wjac-11-1-2
Copyright © 2026 Science and Education Publishing

Cite this paper:
Vijayalakshmi Atla, Dr A. Krishnamanjari Pawar, Bothsa Guru Naidu, K. Laxmi Chandana, K. Sri Padma. Rapid and Sensitive LCMS/MS Method for the Detection and Quantitation of Nitrosamine Drug Substance Related Impurity in Antihypertensive Drug Lercanidipine. World Journal of Analytical Chemistry. 2026; 11(1):15-19. doi: 10.12691/wjac-11-1-2.

Correspondence to: Dr  A. Krishnamanjari Pawar, Pharmaceutical Analysis and Quality assurance division, Andhra University College of pharmaceutical sciences, Andhra University, Visakhapatnam, India. Email: akmpawar@andhrauniversity.edu.in

Abstract

Lercanidipine is a synthetic antihypertensive drug belongs to the dihydropyridines chemical class. Antihypertensive drugs often require long term usage for controlling blood pressure and to prevent cardiovascular risk. Drugs that possess secondary amine functional group are prone to nitrosation and form nitrosamine drug substance related impurities (NDSRI). Nitrosamine impurities are known to cause carcinogenicity in humans and required to be controlled in pharmaceuticals. The present work describes rapid 5.0 minute liquid chromatography mass spectrometry method for the detection and quantitation of potential genotoxic Nitrosamine impurity N-nitroso-des-methyl-lercanidipine impurity D (NNLD) in the Lercanidipine active pharmaceutical ingredient. The developed method validated as per ICH Q2(R2) guideline and shown excellent selectivity, linearity (r2 0.9957), accuracy (average % recovery 90 to 111 %) and precision (%RSD < 8%). The Limit of Detection (LOD) was 0.17 ppm and Limit of quantification was established at 0.5 ppm relative to 5mg per mL Lercanidipine test concentration.

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