Organic Impurity analysis of Levofloxacin Drug Material following USP monograph

User Benefits

- Following USP monograph 41, impurity analysis of levofloxacin drug material was performed on the i-series LC- 2050. System suitability test meets the requirements. - Six organic impurities of trace levels were found with 4 being identified via matching the RRTs to the listed impurities in the monograph.

Introduction

Levofloxacin is a synthetic broad spectrum antibacterial agent which is active against Gram-positive and Gram-negative bacteria. Levofloxacin is currently used in adults for the treatment of respiratory tract infections, urinary tract infections, chronic bacterial prostatitis and skin and soft tissue infections, etc. Monitoring impurities in drug active pharmaceutical ingredient (API) and products is crucial for drug development and throughout the manufacturing process. In this application note, Shimadzu i-Series LC- 2050 was used for system suitability test and organic impurities analysis of levofloxacin API following the USP monograph 41. The separation was performed on a Shim-pack GIST C18 column (L1). This method with high sensitivity and selectivity can eventually be transferred and validated for QA/QC in pharmaceutical laboratories.

February 25, 2022 GMT