*Corresponding author:Rahul Hajare, Department of Health Research, Ministry of Health and Family Welfare, New Delhi, India
Received: June 23, 2018; Published: August 01, 2018
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This is out line work on the process development for the impurity detection of Isatin from synthetic occurring and several new methods have been developed during the pursuit of this research. The article traces the evolution of various approaches and provides a comparison for overall efficiency. UPLC method has been developed and validated for simultaneous estimation of matrix impurity, disregards impurity; specified impurity associated undetectable impurity in pure synthetic formulations. Separation was carried out using column Hypersil ODS C18 (250 mm x 4.6mm x 5μm particle size) in isocratic mode using mobile phase composition pH 6.0 ammonium acetate Buffer: Acetonitrile (68:32) v/v and UV detection at 310 nm. The impurities were eluted at a flow rate of 1.0 mL/ min. The average retention times for matrix impurity, disregards impurity, specified impurity associated undetectable impurity were 2.86 and 3.67 min, 4.54 min respectively. The method was validated according to the ICH guidelines.
Keywords: Matrix Impurity; Disregards Impurity; Specified Impurity Associated Undetectable Impurity; UPLC; Ich Guidelines; Process Development
Abstract| Introduction| Assay Liquid chromatography (2.2.29 European Pharmacopiea 5.0) as described in the test for related substances with the following modifications| Limits| Acknowledgement| References|
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