Development and validation of an HPLC method to analyze ibuprofen and impurities according to the European Pharmacopoeia Abstract
This Application Note describes the development of a fast, accurate,
and reproducible method to analyze ibuprofen and related impurities
according to European Pharmacopoeia (EP) regulations1, using an
Agilent 1120 Compact LC. The experiments described in this
Application Note include determination of precision of areas and reten-
tion times, as well as chromatographic parameters like resolution and
signal-to-noise ratios. The experiments prove precise results from a
system that was optimized for everyday productivity, and they fulfill
Introduction Step 1 – Preparation of individual
Step 2 – Preparation of solution
Step 3 – Preparation of reference
tion from step 2 was added andthe mixture was diluted to 10 mL
(6 µg/mL) of each of the impurities. Experimental Chromatographic conditions System suitability and performance Equipment Preparation of samples Solvents, gradient, and pump settings
main peak must be linear with-out dilution. Number of injections
Verify baseline stability and identify artifacts
Verify stability of response and correctness of
Results and discussion Table 1 Setup for testing system suitability and performance. Retention time (min) Resolution
ria were fulfilled. The requiredsensitivity was obtained for all
Table 2 Results for control sample: resolution and signal-to-noise (S/N) ratio.
peaks and resolution > 1.5 wasachieved for all compounds in the
Compound Retention time (min) (µg/mL) Suitability sample: precision of retention times and areas. (RSD = relative standard deviation; RT = retention time).
was proven. For all components,the criteria for precision of reten-
Residual r standard deviation
tion times and areas were fulfilled,showing that the system can be
Calibration (Setting “Ignore Origin”, y=mx+b, 0.6 to 9 µg/mL for impurities and 0.2 to 3 mg/L for ibuprofen).
the concentration of the referencesolution) to the highest concentra-
correlation results (r>0.999) dur-ing calibration, which is also proof
European Pharmacopoeia 4.2, Council of Europe, 2737-9, 2002. Conclusion
Specifications, Ordering,” Agilent5989-7454ENA, 2008.
use, as well as the lowest cost-of-ownership for standard LC
Substances, Revision 2,http://www.fda.gov/cder/guid-
from a system that was optimizedfor everyday productivity, and to
number 5989-5621EN, 2006.
results show that the instrument iswithin the limits of the regulatoryrequirements for a quality controlenvironment.
The results show explicitly theapplicability of the 1120 LC sys-tem for pharmaceutical testing in QA/QC departments. In additionto the instrument capabilities, the new version of the Agilent
wide range of features for dataanalysis and reporting of theresults. www.agilent.com/chem/1120
Published June 15, 2010Publication Number 5989-9241EN
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