Development and validation of high performance liquid chromatography method for the determination of process relatedimpurities in dapoxetine hydrochloride

Rohith, T. and Ananda, S. (2013) Development and validation of high performance liquid chromatography method for the determination of process relatedimpurities in dapoxetine hydrochloride. International Journal of Research in Pharmacy and Chemistry, 3 (1). pp. 74-82. ISSN 2231-2781

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Abstract

A sensitive and stable High Performance liquid chromatographic method has been developed for the identification of three process related impurities viz impurity-A, impurity-B and impurity-C in Dapoxetine hydrochloride. The method was optimized based on the peak shape and resolution of impurity-A, impurity-B and impurity-C. Phenomenex Luna C18 column (250mm�4.6 mm, 5um) was used for optimization of the method. The mobile phase for A pump consisted of 0.1 trifluro acetic acid in water and for that of B pump it consisted of 0.1 trifluro acetic acid in acetonitrile. The method was validated as per International Conference of Harmonization (ICH) guidelines in terms of quantitation limit (QL), detection limit (DL), linearity, precision, accuracy, specificity and robustness. The QL and DL values for impurity-A were found to be 0.02 and 0.005, for that of impurity-B were found to be 0.028 and 0.009 and for that of impurity-C were found to be 0.048 and 0.016 respectively, with respect to sample concentration. The method was linear within the range of QL to 200 for all the three impurities. Thus, the newly developed method was found to be accurate, efficient and stable. The characterizations of these impurities were carried out for the confirmation of respective structures using nuclear magnetic resonance spectroscopy (NMR). A degradation study was also performed for Dapoxetine hydrochloride.

Item Type: Article
Uncontrolled Keywords: Development and Validation and Dapoxetine Hydrochloride and HPLC and Impurities
Subjects: C Chemical Science > Chemistry
Divisions: Department of > Chemistry
Depositing User: Arshiya Kousar
Date Deposited: 14 Jan 2020 11:25
Last Modified: 14 Jan 2020 11:25
URI: http://eprints.uni-mysore.ac.in/id/eprint/10774

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