HPLC determination of cefotaxime sodium for injection related substances.docVIP

 PAGE \* MERGEFORMAT 14 HPLC determination of cefotaxime sodium for injection related substances [Abstract] improved HPLC determination of cefotaxime sodium for injection in the related substances method. In the United States Pharmacopoeia and European Pharmacopoeia (British Pharmacopoeia) methods, based on the optimization of two different mobile phase systems, using gradient elution of cefotaxime sodium for injection of the related substances were isolated. The results of samples of each component of the separation and the detection sensitivity to satisfy the limits of the determination of requirements related substances. The improved RP  HPLC method can be more real and effective reflection of cefotaxime sodium for injection of the related substances, which can effectively control the product quality. [Keywords:] cefotaxime sodium; the material; high-performance liquid chromatography ABSTRACT To improve the method for determination of related substances of cefotaxime sodium for injection. On the basis of USP and EP (BP) methods, different mobile phase systems were optimized. Gradient elution was applied on the separation of cefotaxime sodium and its related substances. The resolution and sensitivity of related substances were acceptable. The detection limit was 100ng. This method was found to be simple and selective. It could be used to control the quality of product effectively. KEY WORDS Cefotaxime sodium; Related substances; HPLC Cefotaxime sodium for injection (cefotaxime sodium) for the third-generation cephalosporins, broad spectrum anti-bacterial, anti-bacterial activity of strong, widespread clinical application [1,2]. ‘Edition of Chinese Pharmacopoeia ‘1995 measured using microbiological assays cefotaxime sodium, the 2000 edition revised HPLC, it was not until the 2005 edition of the relevant substances have not yet asked. The United States, Europe and the United Kingdom [3 ~ 5] and other countries pharmacopoeia of cefotaxime sodium for injec