Studies On Assay Methods Of Related Substances, Levofloxacin And Glucose In Levofloxacin And Glucose Injection

Objective and background:Levofloxacin and glucose injection is a kind of compound preparation with many degradation products.When its impurity and content are detected, active constituents and impurities may affect each other.Glucose is detected by polarimetric determination according to Chinese Pharmacopoeie(ChP2005) Lavofloxacin Lactate is a levorotatory,which can affect the determination of glucose,, so this method is unsuitable.It is necessary to develope another method for glucose determination.The ultraviolet determination of 5- hydroxymethylfurfural which is one of degradation products of glucose can be interfered by lavofloxacin lactate,so a new method needs to be established.The aim of this paper is to investigate proper methods to detect the related substances,levofloxacm and glucose in levofloxacin and glucose Injection.Method:The related substances in this injection were detected by high performance liquid chromatography under the conditions:octadecyl silane bonded silica gel as stationary phase of column,0.05mol/LCitric acid-1mol/L Ammonium acetate-Acetonitrile(77:1:14)as mobile phase and the detection wavelength at 293nm. Determination of levofloxaci referred to the quality criteria of Levofloxacin Lactate Injection according to Chp(2005).And assaying of glucose was carried out with remaining iodometry method.Results:1.The determination of related substances was carried out with high performance liquid chromatography and the detected three batches samples met for requirements of Chp(2005)(=0.5%),RSD=0.19%(n=6).2.Assaying of Lavofloxacin Lactate was carried out with high performace liquid chromatography which was validated.And the contents of three batches samples were all qualified(93.0%～107.0%of signal quantity).The mean recovery was 100.3%,RSD=0.32%(n=5).3.Content of glucose was detected with remaining iodometry method,its linear range was 0.3%～7.0%with a correlation coefficient of 0.9999,its recovery was 100.1%,RSD=0.18%(n=9),the contents of three batches sample were qualified (95.0%～105.0%of signal quantity).4.5- hydroxymethyfurfural which is one of degradation products of glucose was determined by HPLC and UV detection wavelength at 284nm.Its detection limit was 0.02μg/ml,its recovery was 97.3%--99.8%,RSD was 0.13%(n=5),and its linear range was 2.021-5.517μg/ml with a correlation coefficient of 0.9996.Conclusion:The analytical methods which were established had the characteristics of specificity,easy operating,accuracy and good reproducibility.They can be used for the analysis of Levofloxacin and Glucose Injection.