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Title: | Determination of related substances in ketoprofen injection by RP-HPLC method |
Authors: | LUO, Lei Tan, Mingguo LUO, Yonghuang |
Keywords: | RP-HPLC ketoprofen injection related substances |
Issue Date: | 19-Jul-2019 |
Publisher: | Karachi: Faculty of Pharmacy & Pharmaceutical Sciences University of Karachi |
Citation: | Luo, L., Tan, M., & Luo, Y. (2019). Determination of related substances in ketoprofen injection by RP-HPLC method. Pakistan Journal of Pharmaceutical Sciences, 32(4), 1607-1615. |
Abstract: | The paper aims to establish a RP-HPLC method for the simultaneous determination of six related substances in ketoprofen injection. The separation was performed on a VP-ODS C18 column (4.6mm×250mm, 5μm) with the mobile phase of 6.8% phosphate buffer solution (adjusted to pH3.5 with 85% phosphoric acid)-acetonitrile-water (2:43:55,v/v/v) at a flow rate of 1.2mL·min-1 . The detection wavelength and the injection volume were set at 233nm and 20μL, respectively. Impurity A and C were calculated by external standard method. Main component self-compare method with calibration factor was used to calculate impurity B, D, E, F and main component self-compare method without calibration factor was used to calculate unspecified impurity. Related substances and degraded substances were completely separated from ketoprofen. For impurity A and C, the linear range of determination were separately 0.06 μg·mL-1 ~ 3.6μg·mL-1 and 0.036μg·mL-1 ~ 2.4μg·mL-1 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. |
URI: | http://142.54.178.187:9060/xmlui/handle/123456789/16036 |
ISSN: | 1011-601X |
Appears in Collections: | Issue 4 |
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File | Description | Size | Format | |
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Paper-19.htm | 131 B | HTML | View/Open |
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