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Development and application of LC-MS/MS method for determination of six Nitrosamine impurities in two Sartan drug products as per Procedure 3, USP General Chapter <1469>
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Abstract
In this study, we investigated the suitability of chromatographic conditions, mass spectrometry conditions, and sample preparation procedures when applying Procedure 3, USP General Chapter <1469> under the existing equipment conditions of the National Institute of Drug Quality Control for six nitrosamine impurities: NDMA, NDEA, NDBA, NIPEA, NMBA and NDIPA. We also validated the method on two pharmaceutical product matrices: film-coated tablets containing Losartan potassium and tablets containing Telmisartan. The results showed that the validation criteria were met for both matrices, except for the recovery of NMBA. The quantification limits for the nitrosamines ranged from 0.08 to 0.44 µg/g. Through experimental
procedures, it was observed that the sample matrix significantly affected the analysis of nitrosamine impurities. The method was applied to analyze the six nitrosamines in 12 finished product samples containing Losartan potassium and Telmisartan available on the market.
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Keywords
Sartan, LC-MS/MS, Nitrosamine
References
2. USP General Chapter <1469> Nitrosamine impurities.
3. USP General Chapter <736> Mass spectrometry.
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