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Development and Validation of a Gradient RP-HPLC Method for Quantitative Determination of Potential Manufacturing Impurities in New Drug Apronalide and Pharmaceutical FormulationsBy Ritesh Mishra, Hitesh Malvia, M. Asif Khan
Abstract: Three impurities in apronalide drug substance were detected and quantified using a simple isocratic reverse phase HPLC method. The chromatographic separation was achieved on a Thermo Hypersil gold-CN, 100 A0 5 µm, and 250X4.6 mm using a mobile phase consisting of phosphate buffer (pH-4.6) - Methanol with UV detection at 210 nm and flow rate of 0.8 ml/min. The column temperature was maintained at 250C throughout the analysis. This method …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 1, Issue 1, 2014 · pp. 1–10 Read article →