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2019•PubMedRequires access

Determination of related substances in ketoprofen injection by RP-HPLC method.

Lei Luo, Mingguo Tan, Yonghuang Luo

Open publisher page 3 citations

Abstract

with the correlation coefficient of 0.9999. The average recoveries (n=9) were 98.13% (RSD=0.35%) and 96.32% (RSD=0.43%). The precision and repeatability for method were good. With reference to ketoprofen (retention time =10.06 min), the relative retention time of impurity B, D, E, F were 0.71, 1.46, 0.59, 2.13, respectively, and the relative correction factors were 0.962, 0.938, 0.957, 0.960, respectively. Finally, determined that the contents of impurity A could not be more than 0.3%, any of the contents of impurity B, C, D, E, F and unspecified impurities could not be more than 0.2%, sum of the contents of impurities other than A and C couldn't be more than 0.5%. The method was proved to be simple, rapid, accurate, sensitive and suitable for the simultaneous determination of six related substances in ketoprofen injection.

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with the correlation coefficient of 0.9999. The average recoveries (n=9) were 98.13% (RSD=0.35%) and 96.32% (RSD=0.43%). The precision and repeatability for method were good. With reference to ketoprofen (retention time =10.06 min), the relative retention time of impurity B, D, E, F were 0.71, 1.46, 0.59, 2.13, respectively, and the relative correction factors were 0.962, 0.938, 0.957, 0.960, respectively. Finally, determined that the contents of impurity A could not be more than 0.3%, any of the contents of impurity B, C, D, E, F and unspecified impurities could not be more than 0.2%, sum of the contents of impurities other than A and C couldn't be more than 0.5%. The method was proved to be simple, rapid, accurate, sensitive and suitable for the simultaneous determination of six related substances in ketoprofen injection.

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Available abstract

with the correlation coefficient of 0.9999. The average recoveries (n=9) were 98.13% (RSD=0.35%) and 96.32% (RSD=0.43%). The precision and repeatability for method were good. With reference to ketoprofen (retention time =10.06 min), the relative retention time of impurity B, D, E, F were 0.71, 1.46, 0.59, 2.13, respectively, and the relative correction factors were 0.962, 0.938, 0.957, 0.960, respectively. Finally, determined that the contents of impurity A could not be more than 0.3%, any of the contents of impurity B, C, D, E, F and unspecified impurities could not be more than 0.2%, sum of the contents of impurities other than A and C couldn't be more than 0.5%. The method was proved to be simple, rapid, accurate, sensitive and suitable for the simultaneous determination of six related substances in ketoprofen injection.

Key concepts: Ketoprofen, Repeatability, Chromatography, Chemistry, Impurity, Phosphoric acid, High-performance liquid chromatography, Analytical Chemistry (journal)

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