HPLC Analysis of Bendamustine and Related Impurities

 

Application Notes: Bendamustine is a hydrophobic and basic drug, classified as nitrogen mustard. Two approaches were used to separate bendamustine from related impurities. In one approach, a Primesep 200 HPLC column was used in reversed-phase cation-exchange mode. Primesep D column was also used in reversed-phase cation-exclusion mode. Both methods are alternative to each other. Both can be used to quantify bendamustine in various sample matrices (drug composition, blood, plasma, urine, etc.). Sample preparation is required in the case of biofluids using the Primesep 200 column. Primesep D can be used for direct analysis of bendamustine in blood, plasma and urine. Proteins in the biofuids repel from stationary phase. Sulfuric acid in the mobile phase can be replaced with ammonium formate or acetate for LC/MS and with TFA for ELSD/CAD.

Application Columns: Primesep 200, Primesep D
Application compounds: bendamustine and related impurities
Detection technique: UV, LC/MS, ELSD/CAD

Condition 1

Column Primesep 200, 4.6×150 mm, 5 µm, 100A
Mobile Phase MeCN – 30%
Buffer H2SO4 – 0.1%
Flow Rate 0.6 ml/min
Detection UV, 215 nm

 

Condition 2

Column Primesep D, 4.6×150 mm, 5 µm, 100A
Mobile Phase MeCN – 15%
Buffer H2SO4 – 0.1%
Flow Rate 1.0 ml/min
Detection UV, 230 nm

Description

Class of Compounds
Drug, Chemotherapy, Hydrophilic, Ionizable
Analyzing Compounds Bendamustine

 

Application Column

Primesep 200

The Primesep family of mixed-mode columns offers a wide variety of stationary phases, boasting unprecedented selectivity in the separation of a broad array of chemical compounds across multiple applications. Corresponding Primesep guard columns, available with all stationary phases, do not require holders. SIELC provides a method development service available to all customers. Inquire about our specially-tailored custom LC-phases for specific separations.

Select options

Primesep D

The Primesep family of mixed-mode columns offers a wide variety of stationary phases, boasting unprecedented selectivity in the separation of a broad array of chemical compounds across multiple applications. Corresponding Primesep guard columns, available with all stationary phases, do not require holders. SIELC provides a method development service available to all customers. Inquire about our specially-tailored custom LC-phases for specific separations.

Select options
SIELC Technologies usually develops more than one method for each compound. Therefore, this particular method may not be the best available method from our portfolio for your specific application. Before you decide to implement this method in your research, please send us an email to research@sielc.com so we can ensure you get optimal results for your compound/s of interest.