替硝唑滴丸降解产物的HPLC含量测定  

Determination of Degradation Products of Tinidazole Drop Pills by HPLC

作　　者：夏婷[1] 张瑶[1] 吴丽艳[1] 赵曦[1] 滕利荣[2] 

机构地区：[1]吉林大学珠海学院,广东珠海519041 [2]吉林大学生命科学院,吉林长春130012

出　　处：《北华大学学报（自然科学版）》2013年第2期179-182,共4页Journal of Beihua University（Natural Science）

基　　金：吉林大学珠海学院校内基金项目(201210)

摘　　要：目的考察不同pH对替硝唑滴丸降解产物的影响,指导替硝唑滴丸的制备及质量控制.方法制备替硝唑滴丸,配制成不同pH的滴丸样品溶液,80℃恒温加热,采用高效液相色谱(HPLC)法测定样品中替硝唑和降解产物的含量.结果随着pH的增高,替硝唑含量降低逐渐增快,降解产物的数目和含量逐渐增加.结论替硝唑滴丸在pH 4～5的酸性环境中较中性及碱性环境中质量稳定,有利于制备,并能够确保制剂质量.Objective To study the effect of different pH on degradation products of tinidazole explore a better method for the preparation and quality control of tinidazole drop pills. Method drop pills, and Tinidazole drop pills were prepared, and then samples of the pills were prepared into solutions with different pH values. The solutions were heated at 80 ℃, and then, the tinidazole content and degradation products in them were determined by HPLC. Results The declining rate of tinidazole levels in the solutions accelerated, and the number and the concentration of tinidazole degradation products increased with the raise of pH values. Conclusion Tinidazole drop pills in acidic conditions around pH 4-5 could be more stable than in neutral and alkaline conditions, which may be in favor of the preparation and storage, and the assurance of tinidazole drop pills quality.

关 键 词：替硝唑滴丸 降解产物 PH 高效液相色谱 

分 类 号：R927.2[医药卫生—药学]