Development, validation, and estimation of measurement uncertainty for the quantitative determination of nitrosamines in Sartan drugs using liquid chromatography-atmospheric pressure chemical ionization-tandem mass spectrometry

Autor: Narendra Kumar Nagendla, Hussain Shaik, Seetha Bala Subrahanyam, Deepika Godugu, Mohana Krishna Reddy Mudiam
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Journal of Chromatography Open, Vol 2, Iss , Pp 100053- (2022)
Druh dokumentu: article
ISSN: 2772-3917
DOI: 10.1016/j.jcoa.2022.100053
Popis: In the current study, a feasible and sensitive liquid chromatography-atmospheric pressure chemical ionization tandem mass spectrometry (LC-APCI-MS/MS) method was developed and validated for the determination of eight nitrosamines in Sartan active pharmaceutical ingredients (APIs). The proposed LC-APCI-MS/MS method was validated as per regulatory guidelines. The limit of detection and limit of quantification was found to be in the range of 0.32–1.58 ng/mL, 1.09–4.74 ng/mL, and the recovery was in the range of 86.4–109.6% for Sartan APIs, and 82.1–114.1% for Sartan final products, respectively. The calibration curves of all nitrosamines in the concentration range of 2–100 ng/mL were carried out, and the coefficient of determination (R2) was found to be in the range of 0.9990–0.9999. The robustness of the present method was within the acceptance (
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