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| Determination of impurity L- Cefalexin in Cefalexin by HPLC |
| Wang Xinhui |
| North China Pharmaceutical Corporation Ltd., Beta Branch Factory, Shijiazhuang 052165, China |
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Abstract In order to detect the content of impurities in Cefalexin, this method was established to determine the content of impurity L-Cefalexin in Cefalexin .HPLC was adopted, the chromatographic conditions were as follows, CAPCELL PAK C18 MG‖ column was used, 0.1mol/L sodium dihydrogen phosphate (pH5.0) was used as mobile phase A, methanol was used as mobile phase B, gradient elution was adopted, the flow rate was 1.5 mL /min and the determination was carried out at 220nm wavelength. We have conducted method validation. It confirms that the separation degree of Cefalexin and L- Cefalexin was good under this condition, and the specificity, accuracy, repeatability, detection limit and quantitative limit all met the requirements. The method can be used for the quality control of L- Cefalexin.
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| [ 1 ] 国家药典委员会. 中华人民共和国药典，2020版.
[ 2 ] THE BRITISH PHARMACOPEIAL CONVENTION. 英国药典,BP2019版.
[ 3 ] THE UNITED STATES PHARMACOPEIAL CONVENTION. 美国药典，USP42版.
[ 4 ] THE EUROPEAN PHARMACOPEIAL CONVENTION. 欧洲药典，EP9.8版. |
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