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Determination of Nitrosamine Impurities (N-Nitrosodimethylamine, N-Nitrosodiethylamine, N-Nitrosodiisopropylamine, N-Nitrosoisopropylethylamine, N-Nitrosodibutylamine) in Telmisartan Tablets USP 20 mg, 40 mg and 80 mg by GC-MS/MS. Using column Rtx-5 Amine fused silica capillary column with Base deactivated guard column. The validation of optimized method was carried out in accordance with relevant validation principles. The authenticated procedure was noticed to be specific, precise, linear, accurate and rugged with concentration ranging from limit of quantification (LOQ) to 200% specification level for Nitrosamine Impurities. As per daily dose of Telmisartan Tablets, the specification limits of N-Nitrosodimethylamine is 1.2mcg/gm and other Nitrosamine Impurities is 0.33mcg/gm. In this method the limit of detection for N-Nitrosodimethylamine is 0.12mcg/gm and other Nitrosamine Impurities is 0.033mcg/gm. The established method was productively useful to determine the N-Nitrosamine Impurities in Telmisartan Tablets. Keywords: Gas chromatography coupled with mass spectrometry (GC-MS/MS), Telmisartan tablets USP, Nitrosamine impurities, ICH guideline. |
