LC-MS method development for the quantitation of potential genotoxic impurity 2-Methyl-6-nitro aniline in Telmisartan API

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dc.contributor.authorSuryakala, Duvvurien_US
dc.contributor.authorSusarla, Sivakumaren_US
dc.contributor.authorRao, Bandlamudi Mallikarjunaen_US
dc.date.accessioned2020-10-16T08:56:56Z
dc.date.available2020-10-16T08:56:56Z
dc.date.issued2020-05
dc.description.abstractCurrent work discloses the sensitive LC-MS/MS method development for the trace level determination of genotoxicimpurity 2-Methyl-6-nitro aniline in Telmisartan. 2-Methyl-6-nitro aniline was determined by LC-MS/MS methodin selected ion monitoring mode using LiChrospher RP-18 (100 × 4.6 mm) 5.0 µm column. Gradient technique wasapplied for the elution of analytes using acetonitrile (mobile phase A) and 0.01 M ammonium acetate buffer (mobilephase B) in different ratios. The gradient program (T/%B) was set as 0/5, 2.50/15, 5.00/30, 10.00/50, 15.00/95, and20.00/95. Developed method was validated as per International Conference on Harmonization guidelines. The limit ofdetection and limit of quantitation values found for 2-Methyl-6-nitro aniline were 0.05 and 0.1 µg/ml. The developedmethod serves as an upright tool in quality control for quantitation of 2-Methyl-6-nitro aniline impurity at trace levelsin Telmisartan.en_US
dc.identifier.affiliationsGITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, India.en_US
dc.identifier.citationSuryakala Duvvuri, Susarla Sivakumar, Rao Bandlamudi Mallikarjuna. LC-MS method development for the quantitation of potential genotoxic impurity 2-Methyl-6-nitro aniline in Telmisartan API. Journal of Applied Pharmaceutical Science. 2020 May; 2020 May: 092-096en_US
dc.identifier.issn2231-3354
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/210753
dc.languageenen_US
dc.publisherOpen Science Publishers LLPen_US
dc.relation.issuenumber5en_US
dc.relation.volume10en_US
dc.source.urihttps://dx.doi.org//10.7324/JAPS.2020.10512en_US
dc.subject2-Methyl-6-nitro anilineen_US
dc.subjectTelmisartanen_US
dc.subjectGenotoxic impuritiesen_US
dc.subjectselected Ion Monitoring (SIM)en_US
dc.subjectICH guidelinesen_US
dc.titleLC-MS method development for the quantitation of potential genotoxic impurity 2-Methyl-6-nitro aniline in Telmisartan APIen_US
dc.typeJournal Articleen_US
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