Application of the new data processing method for photodiode array detector in the analysis of drug substances

Łukasz Jedynak ,  Maria Puchalska ,  Joanna Zagrodzka ,  Wojciech Łuniewski ,  Łukasz S. Kaczmarek 

Pharmaceutical Research Institute, Rydygiera 8, Warsaw 01-793, Poland

Abstract

Intelligent Dynamic Range Extension Calculator (i-DReC) is a new data processing method for photodiode array detector available in LabSolutions software by Shimadzu. It allows to extend the linear range of the chromatographic method by shifting the chromatographic profile to the wavelength where target signal is not saturated.

In the analysis of active pharmaceutical ingredients (API’s) it is necessary to determine both assay of the drug substance itself and content of impurities in drug substance. As impurities must be determined at relatively low levels, it is often not possible to select such analytical conditions which allow to determine both API assay and content of impurities in one chromatographic run. Concentration of drug substance in method for determination of its purity is often outside the linear range of applied detector and additional method for drug substance assay must be developed.

Temozolomide is a drug which is used for the treatment of primary brain tumours. Impurity profile of temozolomide substance manufactured at Pharmaceutical Research Institute imposed the necessity to use separate methods for determination of assay and purity of the API. Application of i-DReC allows to determine assay of temozolomide using the method for purity determination although temozolomide signal is saturated. Comparison of results of assay determination with the use of i-DReC with the results obtained from the separate assay method revealed good coherence between them. Thus it is possible to use only one analytical procedure instead of two which allows to reduce the solvent consumption, lower the costs of analysis and save time.

Acknowledgment

The study was supported by European Union under European Regional Development Fund No. UDA-POiG.01.03.01-069/08-00 “Innovative technologies of oncological medicines of special therapeutic and social importance”.

The authors would like to kindly acknowledge Shim-Pol for the opportunity to test the UHPLC Nexera X2 system with LabSolutions software.

 

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Presentation: Poster at IX Multidyscyplinarna Konferencja Nauki o Leku, by Łukasz Jedynak
See On-line Journal of IX Multidyscyplinarna Konferencja Nauki o Leku

Submitted: 2014-03-14 08:38
Revised:   2014-04-29 11:40