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

Vijayalakshmi Atla^1, , Dr A. Krishnamanjari Pawar^1, , Bothsa Guru Naidu², K. Laxmi Chandana¹ and K. Sri Padma¹

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

Cite this paper:
Vijayalakshmi Atla, Dr A. Krishnamanjari Pawar, Bothsa Guru Naidu, K. Laxmi Chandana and 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

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.

Keywords:
Lercanidipine NDSRI LC-MS-MS Validation

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