| Objective: Drug quality analysis and evaluation is an important content of drug quality control,and the most critical link to ensure people’s drug safety.Based on pharmacopoeia of various countries,this paper optimizes the analysis methods for related substances of cefoxitin sodium for injection and tetracycline hydrochloride.The analysis and quality evaluation system of cefoxitin sodium for injection and tetracycline hydrochloride was established to provide effective suggestions for related substances in pharmacopoeia.Methods: According to the pharmacopoeia method,the existing analysis methods of cefoxitin sodium for injection and tetracycline hydrochloride were optimized.Through accelerated test and destruction test,the related substances of cefoxitin sodium for injection were collected and analyzed.The impurity spectrum of cefoxitin sodium for injection was established and optimized.The effect of different column parameters on the separation of tetracycline hydrochloride related substances was analyzed,and the potential relationship between column parameters and the separation degree of related substances and the number of theoretical plates was investigated.To provide reasonable suggestions for the revision and improvement of the quality standards about cefoxitin sodium for injection and tetracycline hydrochloride.Results: The degradation products and cleavage pathway of cefoxitin sodium for injection under different destruction conditions were analyzed,a comprehensive impurity spectrum of cefoxitin sodium for injection was established,.The chromatographic analysis method was optimized,and the main influencing factors for the analysis of related substances were determined as column parameter H,followed by mobile phase p H,acetonitrile ratio,column temperature and end time.The original analysis method was supplemented and explained.Based on the column characterization method established by Snyder et al.,column parameter C was determ ine to be the main factor affecting the separation degree of 4-differential tetracycline and tetracycline,and the optimal range of C was determined to be between-0.118 and0.772,which could meet the separation requirements.The model equation between the number of plates and column parameters of aureomycin theory was established.The chromatographic column was used to verify the equation with high accuracy.Conclusion: In this paper,the impurity spectrum of cefoxitin sodium for injection was established,the impurity structure and source were determined.The chromatographic method and the production process of cefoxitin sodium for injection were optimized.The relationship between the chromatographic column parameters and the separation degree of tetracycline hydrochloride related substances and the number of theoretical plates was established.Screening the chromatographic column according to the column parameters can avoid blind attempts in experiments. |
PDF Full Text Request