CE method for the in-process control of the synthesis of active substances conjugated with gold nanoparticles
PBN-AR
Instytucja
Sieć Badawcza Łukasiewicz - Instytut Farmaceutyczny
Informacje podstawowe
Główny język publikacji
angielski
Czasopismo
Journal of Pharmaceutical and Biomedical Analysis (35pkt w roku publikacji)
ISSN
0731-7085
EISSN
Wydawca
ELSEVIER SCIENCE BV
DOI
URL
Rok publikacji
2017
Numer zeszytu
Strony od-do
52-58
Numer tomu
141
Link do pełnego tekstu
Identyfikator DOI
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Autorzy
(liczba autorów: 3)
Pozostali autorzy
+ 1
Słowa kluczowe
angielski
Capillary electrophoresis
Genistein
In-process control
Pemetrexed
Validation
Streszczenia
Język
angielski
Treść
A fast capillary electrophoresis method was developed and validated for the in-process control (IPC) of the synthesis of active substances (APIs) with gold nanoparticles (AuNPs). The capillary electrophoresis method was key to ensure that the reaction step conducted in order to obtain AuNP and API conjugates will produce the expected product without the presence of free APIs, which is a critical parameter determining the quality of the synthetic material. Capillary electrophoresis was performed using uncoated fused-silica capillaries with the effective length of 40cm, 50μm i.d. and the background electrolyte consisted of 20mM borate buffer (pH 8.5) with the application of hydrodynamic injection 50mbar/5s, voltage 20kV, temperature of the capillary cassette 25°C and UV detection at 261nm for GE, 541nm for AuNP-GE, 227nm for PE and 535nm for AuNP-PE. During validation the specificity, linearity, accuracy, precision, range, and stability of the sample solution were confirmed. The linear regression (R2=0.999) between the corrected peak areas of the analytes and their amount was fulfilled in the range from 2.4μg/mL to 0.3mg/mL for genistein and from 4.6μg/mL to 0.6mg/mL for pemetrexed. Within this range the method was proved to be accurate (99.0% for genistein and 99.9% for pemetrexed) and precise for both analytes with the intra-day RSD values of 0.77% and 0.97% for the migration time of genistein and pemetrexed, respectively. The inter-day RSD values were 1.90% and 2.27% for the migration time of genistein and pemetrexed, respectively. The LOD and LOQ values for pemetrexed were 1.4μg/mL and 4.6μg/mL, respectively, and for genistein 0.72μg/mL and 2.4μg/mL, respectively. The results obtained during the validation indicate that the method is sufficient to be applied for the IPC of the synthesis of APIs with gold nanoparticles.
Inne
System-identifier
PX-59a6fc81d5decf2a9c0c39dc
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