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Abstract
A fast, selective, and sensitive reversed phase ultra performance liquid chromatographic (UPLC) method employing C-18 column has been developed and validated for the simultaneous analysis of doripenem (DOR) and its degradation products, Impurity 1[5-(1-Carboxy-2-hydroxypropyl)-4-methyl-3-(5-((sulfamoylamino) methyl)pyrrolidin-3-ylthio)-4,5-di hydro-1H-pyrrole-2-carboxylic acid], and Impurity 2 [2,2′-(2,7-Dimethyl-5,10-dioxo-1,6-bis(5-((sulfamoylamino)methyl)pyrrolidin-3-yl thio)-2,3,5,7,8,10-hexahydropyrrol[1,2-a:1′,2′-d]pyrazine-3,8-diyl)bis(3-hydroxybutan oic acid)]. The best separations were achieved by a gradient elution with mobile phase consisting of a mixture of phosphate buffer 10 mM, pH 6.0, at a flow rate of 1.0 mL per minute. Column temperature was selected as 45°C where the detection was carried out at 210 nm and 300 nm. The method was found to be precise, linear, accurate, and used to quantify the impurities and potency during stability sample analysis of doripenem.
ACKNOWLEDGMENT
The authors are thankful to the management of Hospira for providing the opportunity to carry out this work.