Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry
ISSN: 0975-413X
Pragnesh Patani
Department of Pharmaceutics, Khyati Pharmacy College, GTU, Ahmedabad, IndiaPublications
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Research Article
Impurities Profiling of Method Development and Validation of Etravirine (ETR) in their Dosage Forms by Chromatography Method as Per International Conference on Harmonisation Guidelines
Author(s): Nirav R. Soni* and Pragnesh Patani
Objective: An accurate, precise, rapid and economical reverse phase High Performance Liquid Chromatography (HPLC) method has been developed and validated for the estimation of etravirine in pharmaceutical dosage forms, using PDA detector. Method: Elution was carried out using a mobile phase-A and B consisting of HPLC grade and flow rate was set on 1 ml/minute at 310 nm wave length. The retention time for Etravirine (ETR), impurity-1 and impuriey-2 was found to be 15.813, 12.043 and 17.704 respectively minutes. Result: Analytical method was developed using HPLC Shimadzu (with power stream) gradient chromatographic technique. Data were passed through the spinchrom software. Separation was achieved on Xselect HSS T3 (150 × 4.6 mm, 3.5 μm) column and using mobile phase A (Buffer) was used at pH 4.0 and mobile phas.. Read More»
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