TY - JOUR
T1 - Separation and estimation of process-related impurities of gefitinib by reverse-phase high-performance liquid chromatography
AU - Chandrashekara, Karunakara A.
AU - Udupi, Aparna
AU - Reddy, Chandrasekara G.
N1 - Funding Information:
We thank Dr Anil Kush, CEO, Vittal Mallya Scientific Research Foundation, for his encouragement and support.
Copyright:
Copyright 2014 Elsevier B.V., All rights reserved.
PY - 2014/9
Y1 - 2014/9
N2 - A simple and rapid reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous separation and estimation of gefitinib (an anti-cancer drug) and its process-related impurities. Five process-related impurities of gefitinib were separated on an Inertsil ODS-3V column (250 3 4.6 mm i.d.; particle size 5 mm) using 130 mM ammonium acetate and acetonitrile (63:37, v/v) as mobile phase (pH 5.0) with a photodiode array (PDA) detector. The correlation coefficients for gefitinib and its processrelated impurities were in the range of 0.9991-0.9994 with limit of detection and limit of quantification in the range of 0.012-0.033 and 0.04-0.10 μg/mL, respectively. The recovery values were in the range of 98.26-99.90% for gefitinib and 95.99-100.55% for processrelated impurities, while precision values were less than 3%. The method was found to be specific, precise and reliable for the determination of gefitinib and its impurities in gefitinib bulk drug.
AB - A simple and rapid reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous separation and estimation of gefitinib (an anti-cancer drug) and its process-related impurities. Five process-related impurities of gefitinib were separated on an Inertsil ODS-3V column (250 3 4.6 mm i.d.; particle size 5 mm) using 130 mM ammonium acetate and acetonitrile (63:37, v/v) as mobile phase (pH 5.0) with a photodiode array (PDA) detector. The correlation coefficients for gefitinib and its processrelated impurities were in the range of 0.9991-0.9994 with limit of detection and limit of quantification in the range of 0.012-0.033 and 0.04-0.10 μg/mL, respectively. The recovery values were in the range of 98.26-99.90% for gefitinib and 95.99-100.55% for processrelated impurities, while precision values were less than 3%. The method was found to be specific, precise and reliable for the determination of gefitinib and its impurities in gefitinib bulk drug.
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U2 - 10.1093/chromsci/bmt116
DO - 10.1093/chromsci/bmt116
M3 - Article
C2 - 23897663
AN - SCOPUS:84906700696
SN - 0021-9665
VL - 52
SP - 799
EP - 805
JO - Journal of Chromatographic Science
JF - Journal of Chromatographic Science
IS - 8
ER -
