Analytical Method Development Using HPLC for Investigation of the Quality of the Marketed Cephalosporins(Thai)

Abstract

A suitable mobile phase for the column of C18 Hypersil 5 μm 250x3.9 mm in this study is the mixture of acetonitrile and water containing 0.4% phosphoric acid and 10 mM tetraethylammonium bromide. The proportion of acetronitril was varied from 15-20%. The column was operated at a flow rate of 0.5 cm3 /min. The injection volume was 10 μl. Detection was at a wavelength of 260 nm. The method proved to adequately separate the degradation compounds from the parent compounds of cefoxitin, cefazolin, cefotaxime, ceftazidime and cephalexin. The method has also been validated for quantitative analysis. Samples of cefoxitin, cefazolin, cefotaxime and ceftazidime in intravenous form have been investigated with emphasis on the level of degradation products. The percent of peak purity from chromatograms was used to justify the quality of the products. There was found to be no difference between the generic products and the original products. The higher price of the products doesn’t relate to the purity of the products in this study. There are many generic products of cephalexin capsules on the market. Content uniformity and dissolution testing have been chosen to investigate the quality of the products. It was found that every sample met the standard of The United States Pharmacopeia 24 and National Formulary 19 (USP 24). The price is also unable to indicate the quality of cephalexin capsules. However, a bioequivalence study of the products, which was out of the scope of this study, may be a better way of evaluate the quality of the products.