Your browser doesn't support javascript.
loading
Impurity analysis and quality evaluation for commercial levofloxacin formulations using LC-MS/MS method / 药学学报
Acta Pharmaceutica Sinica ; (12): 444-2016.
Article in Chinese | WPRIM | ID: wpr-779190
Responsible library: WPRO
ABSTRACT
The study aims to develop a rapid, specific and sensitive method for quantitative analysis of trace impurities in levofloxacin formulation using LC-MS/MS. The quality of the different formulations from 19 plants was evaluated in the contents of the impurities. The results indicated that there were 5 impurities in the samples, and the content was different in the products with same formulation by different plants. The products of 3 plants were in good quality with impurities level under 0.01%. Levofloxacin N4'-methyl quaternary impurity was first reported as the formulation impurity. The impurities were tightly correlated to the reservation of drug, process control of formulation and storage during transportation. The results suggest that our method is sensitive and specific to detect the trace impurities in formulation, and can be used to monitor the quality of commercial drug product.

Full text: Available Index: WPRIM (Western Pacific) Language: Chinese Journal: Acta Pharmaceutica Sinica Year: 2016 Type: Article

Similar

MEDLINE

...
LILACS

LIS

Full text: Available Index: WPRIM (Western Pacific) Language: Chinese Journal: Acta Pharmaceutica Sinica Year: 2016 Type: Article