Abstract
LC-MS method development for the quantitation of potential genotoxic impurity 2-Methyl-6-nitro aniline in Telmisartan API
Highlights
Telmisartan (Fig. 1a), is an important antihypertensive drug of the Angiotensin-II receptor blockers category
Current work discloses the sensitive LC-MS/MS method development for the trace level determination of genotoxic impurity 2-Methyl-6-nitro aniline in Telmisartan. 2-Methyl-6-nitro aniline was determined by LC-MS/MS method in selected ion monitoring mode using LiChrospher RP-18 (100 × 4.6 mm) 5.0 μm column
Analytical method stability, sensitivity is affected by the sample preparation in trace level analysis of Genotoxic Impurities in a drug substance
Summary
Telmisartan (Fig. 1a), is an important antihypertensive drug of the Angiotensin-II receptor blockers category. Current work discloses the sensitive LC-MS/MS method development for the trace level determination of genotoxic impurity 2-Methyl-6-nitro aniline in Telmisartan. 2-Methyl-6-nitro aniline was determined by LC-MS/MS method in selected ion monitoring mode using LiChrospher RP-18 (100 × 4.6 mm) 5.0 μm column.
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