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A stability-indicating UPLC method has been developedand validated for the determination of related substances of Posaconazole with itsfour related substances Hydroxytriazole, Tosylated compound, Deshydroxy posaconazoleand Benzylated posaconazole in the drug substance. Forthwith simple UPLC chromatographicseparations were achieved on a Waters Acquity BEH shield C18 100 mmlength, 2.1 mm internal diameter and 1.7 μm particle size with a mobile phase containing 0.1% Orthophosphoric acid i.e. 1 mL in 1000 mL water in gradient combination with acetonitrile ACN at a flowrate of 0.5 mL-min and the eluent were monitored at 210 nm. As a result, the resolutionof Posaconazole from any of impurities was found to be greater than 2.0. The testsolution and spiked solutions were found to be stable in the diluent for 48 h. Forthe purpose method to be stability indicating, forced degradation studies were conductedand the method resolved the drug from its known impurities, stated above, and fromadditional impurities generated when POS subjected to forced degradation; themass balance was found close to 100%. Regression analyses indicate correlation coefficientvalue greater than 0.999 for Posaconazole and its known impurities. The LOD forPosaconazole and the known impurities was at a level below 0.05%. The method hasshown good, consistent recoveries for known impurities 89% - 106%. To summarise,the method was found to be accurate, precise, linear, specific, sensitive, rugged,robust, and stability-indicating.

KEYWORDS

Posaconazole, Hydroxytriazole, Tosylated, Deshydroxy Posaconazole, Benzylated Posaconazole, Stability-Indicating, ICH Guidelines, UPLC

Cite this paper

Prasad, V. , Reddy, V. and Aparna, P. 2015 Validated Gradient Stability Indicating UPLC Method for the Determination of Related Substances of Posaconazole in Bulk Drug. American Journal of Analytical Chemistry, 6, 965-976. doi: 10.4236-ajac.2015.612092.





Author: Vadlamanu Durga Prasad1*, Vanga Ranga Reddy2, Pasula Aparna3

Source: http://www.scirp.org/



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