Impurity Analysis And Establishment Of Detection Method For Dexamethasone Sodium Phosphate Injection

Dexamethasone Sodium Phosphate is a long-acting glucocorticoid drug with remarkable effect and low price.It has been known as the "king of corticosteroid drugs".In recent years,with the continuous increase in the use of dexamethasone sodium phosphate injections,reports of adverse reactions becomes common.In this article,a total of 242 batches of dexamethasone sodium phosphate injection(containing 11 powders)were collected from 31 provinces across the country.The pH value,impurities content,bacterial endotoxin,loading capacity,assay,loss on drying and so on were measured according to the requirements of the national standard as quality evaluation.In order to improve the quality of Dexamethasone Sodium Phosphate Injection,the exploration of the improvement of the test method and the influence of the impurity content factor were carried out.The results were following:1.Among the tested dexamethasone sodium phosphate injection impurity indices,the impurity I,and the sum of impurity I and other impurities content exceeded the product standard,and the failure rate was 3.9%.Therefore,quality control should be strengthened in the production of this injection,and market supervision should be strengthened during sales.2.By exploring the affected factors of the detection conditions of impurities,adding sulfur/sulfite detection items in solution,and putting Raman and near-infrared fast detection methods into use,the detection method for impurities of dexamethasone sodium phosphate injection was improved.Dexamethasone Sodium Phosphate Injection was used as a material to explore the conditions that affect the detection of impurities,which showed that when the pH value of the solution was adjusted to 6.5,the reaction temperature was 65℃,and the reaction time was 24 hours,the amount of impurity I in the sample was the largest.At the same time,the structure of the impurity was confirmed,the correction coefficient was proposed,and the impurity detection method was perfected,which improved the accuracy of the detection result.In view of the generality of the use of antioxidants in dexamethasone sodium phosphate products and the fact that there is no limit to the requirements,under the conditions obtained above,the determination of sulfate and sulfite in the sample solution was established by ion chromatography,and the method of antioxidant content in the product was set up.In addition,in order to meet the needs of market supervision,a fast inspection method based on Raman spectroscopy and near-infrared spectroscopy was established,and important judgment parameters such as the correlation coefficient threshold of 0.95 and different Cl values to distinguish products from different manufacturers were proposed.3.Using dexamethasone sodium phosphate injection as material,the correlation between production,use and the formation of impurities was analyzed.With strong light and hydrogen peroxide as the destruction conditions,the amount of impurities in the different destruction solutions was measured.With strong light and hydrogen peroxide as the destruction conditions,the amount of impurities in the different destruction solutions were measured,and the amount of impurities generated in the sample under the hydrogen peroxide destruction condition was the most as a result.By measuring impurities under different storage time,various sterilization process,the imparity amount of antioxidants added,and the presence or absence of complexing agent,we came out with the results that the longer the storage time,the more antioxidants are added,and the greater the amount of impurities in the absence of the complexing agent,the less generation of impurities will caused by sterilization process.