Abstract
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 (<15% RSD) for system suitability. The measurement uncertainty was determined for this method, and the expanded uncertainty was found to be in the range of 16.3–25.9% for Sartan APIs and 8.41–15.6% for Sartan drug products. The precision and recovery were found to be major sources which can induce the uncertainty during the measurement of nitrosamines in Sartan API and Drug products with the developed and validated method.
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