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- W2328740613 abstract "A simple, sensitive and rapid liquid chromatography (LC) - electrospray ionization (ESI) - mass spectrometry (MS)/MS method has been developed and validated for the trace analysis (>1 ppm level) of para chloroaniline, a genotoxic impurity, in Efavirenz drug. The chromatographic separation was achieved on a hypersil BDS (150 × 4.6 mm, 5 μm) column using a mobile phase consisting of 5 mM ammonium acetate buffer (pH 4) and acetonitrile (60:40, v/v) at fl ow rate of 0.7 mL/min and elution was monitored at 305 nm. The active pharmaceutical ingredient-4000 LC-MS/MS was operated on an ESI equipped with an ESI interface operated in positive ionization (single reaction monitoring) mode and it is able to quantitate up to 0.3 ppm of para chloroaniline. The newly developed method was validated as per ICH guidelines." @default.
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- W2328740613 date "2015-01-01" @default.
- W2328740613 modified "2023-09-27" @default.
- W2328740613 title "Method Development and Validation for Quantitative Determination of Para Chloroaniline, an Impurity, in Efavirenz Active Pharmaceutical Ingredient by Liquid Chromatography - Electrospray Ionization - Mass Spectrometry/Mass Spectrometry" @default.
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