Quantification of potential impurities by a stability indicating HPCL method in Desvenlafaxine Succinate Monohydrate Active pharmaceutical ingredient

Rohith, T. and Ananda, S. (2012) Quantification of potential impurities by a stability indicating HPCL method in Desvenlafaxine Succinate Monohydrate Active pharmaceutical ingredient. International Journal of Research in Pharmacy and Chemistry, 2 (4). pp. 947-956. ISSN 2231-2781

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Abstract

A sensitive, selective and stability indicating reverse phase method has been developed for the quantitative determination of potential impurities of Desvenlafaxine succinate monohydrate active pharmaceutical ingredient. Efficient chromatographic separation was achived on C8 stationary phase. Forced degradation study confirmed that the newly developed method was specific and selective to the degradation products. Major degradation of the drug substance was found to occur under oxidative stress conditions to form desvenlafaxine N-oxide. The method was validated according to ICH guidelines with respect to specificity, precision, linearity and accuracy. Regression coefficient value was greater than 0.999 for Desvenlafaxine succinate monohydrate impurities. Detection limit of impurities were in the range of 0.002-0.016% indicating the high sensitivity of the newly developed method. Accuracy of the method was established based on the recovery obtained between 94.65% and 101.05% for all impurities.

Item Type: Article
Uncontrolled Keywords: Desvenlafaxine succinate monohydrate, validation, impurity, Forced degradation.
Subjects: C Chemical Science > Chemistry
Divisions: Department of > Chemistry
Depositing User: MUL SWAPNA user
Date Deposited: 14 Aug 2019 09:23
Last Modified: 14 Aug 2019 09:23
URI: http://eprints.uni-mysore.ac.in/id/eprint/6374

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