METHOD DEVELOPMENT AND VALIDATION OF FIVE NITROSAMINES IMPURITIES CONTENT IN TELMISARTAN DRUG SUBSTANCE BY GC-MS/MS

A proficient GC-MS/MSS method was developed for determination of N-Nitrosodimethylamine, N-Nitrosodiethylamine, N-Nitrosodiisopropylamine, N-Nitrosoisopropylethylamine, N-Nitrosodibutylamine impurities in Telmisartan Drug Substance using column Rtx-5 Amine (30m length X 0.32mm diameter) 1.5µm film thickness, Part No.: 12369, Make: Restek.  Helium is used as Carrier gas at with Linear velocity of 44.3 cm/sec. The proposed method was validated for System suitability, Specificity, Linearity, LOD and LOQ, Method precision, Intermediate precision and Recovery. All the parameters were found within the acceptable limits. Linearity in the range of LOQ to 150% for each impurity. The established methodology was commercially useful, specific, accurate, precise and suitable for the analysis of Nitrosamines impurities in Telmisartan drug substance

Keywords: Gas chromatography with mass spectrometry (GC-MS/MS), Telmisartan drug substance, Nitrosamine impurities, ICH guideline and Method Validation.