Development and Validation of a Single Quadrupole LC/MS Method for the Trace Analysis of Six Nitrosamine Impurities in Valsartan

Xu, Qun; Li, Qiyao; Belsky, Jennifer L.; Min, Donald; Biba, Edmond; Gump, Edwin; Simpson, John T.

doi:10.2139/ssrn.3854535

Cited by 2 publications

(2 citation statements)

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“…In a study by Schmidtsdorff and Schmidt, a supercritical fluid chromatography (SFC) method was developed to simultaneously determine NAs (NDMA, NDEA, NMEA, Nnitrosodi-n-propylamine (NDnPA), NDPA, NDBA, Nnitroso diphenylamine (NDPhA), NPyr, N-nitroso piperidine (NPip), NMor) at ppb levels in the sartan drugs valsartan and losartan (Schmidtsdorff and Schmidt, 2019). In another study by Xu et al (2021) an LC-MS/MS method was developed to analyze NAs (Nnitroso dimethylamine (NDMA), N-nitroso diethylamine (NDEA), N-nitroso diisopropylamine (NDIPA), N-nitroso ethyl isopropylamine (NEIPA), N-nitroso dibutylamine…”

Section: Discussionmentioning

confidence: 99%

“…(NDBA), and N-nitroso methyl aminobutyric acid (NMBA)) as impurities in a valsartan sample. The calibration range for these NA impurities in valsartan was 0.05 -3.6 ppm (Xu et al, 2021). Furthermore, Wohlfart et al conducted a study in 2021 where they developed an LC-MS/MS method to quantify the amount of 4-methyl-1-nitrosopiperazine (MeNP) impurity in rifampicin.…”

Section: Black Sea Journal Of Health Sciencementioning

confidence: 99%

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Determination of Nitrosamines in Various Pharmaceuticals at Variable Temperatures

CANBOLAT,

AYDIN

2024

Black Sea Journal of Health Science

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Nitrosamines have been classified as potent genotoxic agents for humans by the International Agency for Research on Cancer. Our study aimed to determine the levels of nitrosamine impurities that could be formed in the content of drugs under different temperature conditions during their shelf life using chromatographic analysis. Eleven drugs in pharmacies were subjected to long-term exposure at two different temperatures. Twelve nitrosamine impurities of all samples were performed using LC-MS/MS. When the impurity levels of the analyzed drugs were examined, no nitrosamine impurity was detected in any drugs. Our study revealed that if no impurity was detected under storage conditions, there was no impurity formation even when the temperature was increased. When impurity formation is effectively prevented during the manufacturing stage, the risk of impurity occurrence during the shelf-life of drugs belonging to the same group is estimated to be low.

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Section: Discussionmentioning

confidence: 99%

Section: Black Sea Journal Of Health Sciencementioning

confidence: 99%