Page 6 - Shimadzu Co-Sense Series

Using Co-Sense for BA for Cleaning Validation

Though cleaning validation for pharmaceutical production equipment requires high-sensitivity analysis, samples are often obtained
as dilute organic solvents. As a result, samples may need to be concentrated by pretreatment, which can reduce throughput.
Co-Sense for BA can also be used to improve efficiency in cleaning validation applications by allowing samples to be injected directly
in large volumes without having to first concentrate them.

Issues for Cleaning Validation

Reversed phase mode analysis, which involves injecting large large volumes for high-sensitivity analysis. In addition, ordinary
volumes of organic solvents or other solvents with strong trap injections may reduce recovery rates due to elution of
elution properties as the sample solvent, tends to result in poor target components from the trap column. As a result, in LC
peak shapes. Cleaning validation for pharmaceutical production analysis for cleaning validation, samples are often concentrated
equipment often involves samples with ethanol or other organic in advance, leading to decreased throughput.
solvents used as the sample solvent, which can impede injecting

Isopropylantipyrine
Isopropylantipyrine

50 µL injection 100 µL injection
10 µL injection 10 µL injection

Direct Injection Trap Injection

Example of Isopropylantipyrine Ethanol Solution Analysis Using a Traditional System
With large-volume injections using the direct injection method, the isopropylantipyrine peak shows a leading edge from the impact
of the sample solvent. In addition, with trap concentration without on-line dilution, the recovery rate is decreased due to elution
from the trap column because of the impact of the sample solvent.

Superior Peak Shape and Recovery Rate Due to Dilution Trap

When injecting samples using the Co-Sense for BA system,
Isopropylantipyrine
samples are diluted on-line with water or a buffer solution as
they are delivered to the trapping column. This is applicable
even for large injection volumes of organic solvents.
Consequently, this allows reliable trapping concentration even if
a guard or other generic column is used as the trap column.
In addition, the target components are introduced to the
analysis column by valve switching after they are adequately
concentrated on the trap column, so superior peak shapes can
be obtained. High-sensitivity analysis of isopropylantipyrine in 100 µL injection
ethanol is difficult for traditional systems, but with Co-Sense for
10 µL injection
BA, approximately 100 % recovery rate and excellent peaks
shapes are obtained even with 100 µL injections.
Example of Isopropylantipyrine Ethanol Solution Analysis Using Co-Sense for BA

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