Synthesis and Characterization of Impurities of Eletriptan and its HPLC Method Development and Validation
A simple, precise, rapid and accurate HPLC method was developed and validated for the identification and evaluation of N-acetyl 5- (phenyl sulfonylethen 2-yl) indole and 5- (phenyl sulfonyl ethen2-yl)-1H-indole impurities of eletriptan formed during Eletriptan Synthesis. The synthesis of the impurity standard with the proposed structure is the important step in impurity profiling. Characterization of these impurities are done by using instruments like GC-MS ,NMR and FTIR. Separation was carried on a Waters 1525 HPLC system with Breeze software, Waters 2489 UV/Visible detector and Waters Xterra Phenyl C18 analytical column (250mm x4.6mm: 5 µ) was operated in a gradient mode at a flow rate of 1 ml/min with detection wavelengh of 225nm by an injection volume of 10ul. The method is Validated as per ICH guidelines by determining its specificity, accuracy, precision, linearity, ruggedness, robustness and system suitability.
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