Validation of an HPLC Method for the Determination of Imatinib Mesylate in Pharmaceutical Dosage

Rosasco, María Ana; Moyano, María Alejandra; Pizzorno, M. T.; Segall, Adriana Inés

doi:10.1080/10826070500330976

Cited by 8 publications

(3 citation statements)

References 6 publications

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“…Several analytical methods for the determination of imatinib by spectrophotometry [2,3], HPLC [4][5][6][7][8][9][10][11][12] and LC/MS [13] have been reported. The aim of the present work was to develop and validate a better sensitive RP-HPLC method that can be implemented for the quantification of imatinib in bulk as well as in its tablet dosage forms when compared to the data of previous established method [4][5][6][7][8][9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

Validation of Assay Indicating Method Development of Imatinib in Bulk and Its Capsule Dosage Form by Liquid Chromatography

Sahoo¹,

Sahu²,

Alagarsamy³

et al. 2015

Ann Chromatogr Sep Tech

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A novel, simple and economic reverse phase High Performance Liquid Chromatography (RP-HPLC) method has been developed for the quantification of Imatinib in bulk and capsule dosage form with greater precision and accuracy. Separation was achieved on Analytical technologies, C-18, (250mm*4.6mm) column in isocratic mode with mobile phase consisting of acetonitrile: potassium dihydrogen phosphate buffer (pH 2.5) (30:70v/v) with a flow rate of 0.8 mL/min. The detection was carried out at 268 nm. The retention time of Imatinib was found to be 2.67 min. The method was validated as per ICH guidelines. Linearity was established for Imatinib in the range 5-35 μg / ml with r2 value 0.996. The percentage recovery of Imatinib was found to be in the range 99.49-99.67 %. The high recovery and low relative standard deviation confirm the suitability of the proposed method for the estimation of the drug in bulk and capsule dosage forms. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible for the determination of Imatinib for quality control level.

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Section: Introductionmentioning

confidence: 99%

Validation of Assay Indicating Method Development of Imatinib in Bulk and Its Capsule Dosage Form by Liquid Chromatography

Sahoo¹,

Sahu²,

Alagarsamy³

et al. 2015

Ann Chromatogr Sep Tech

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“…The developed high performance liquid chromatography (HPLC) methods utilize either mass spectrometry (MS) [13,14,17,19,21,[25][26][27][28], ultra-violet (UV) [4,[8][9][10][11][12]15,16,18,22,24,[29][30][31]20] or high-performance thin layer chromatography (HPTLC) [7]. In general, the HPLC-UV method is the most widely used and is reported to be the most suitable for trough IM plasma level determination in clinical practice [15].…”

Section: Introductionmentioning

confidence: 99%

“…To date, there are many published methods for the detection of IM in pharmaceutical formulations [7][8][9][10][11][12], IM metabolite profiling [9,13] and different biological specimens, including blood [14], human plasma [4,[14][15][16][17][18][19][20][21][22][23], cerebrospinal fluid [24], urine [24], animals [25][26][27], insect models [13,28], cell lines [29] and bacterial lysate [24]. The developed high performance liquid chromatography (HPLC) methods utilize either mass spectrometry (MS) [13,14,17,19,21,[25][26][27][28], ultra-violet (UV) [4,[8][9][10][11][12]15,16,18,22,…”

Section: Introductionmentioning

confidence: 99%

Method development and validation for the simultaneous determination of imatinib mesylate and N-desmethyl imatinib using rapid resolution high performance liquid chromatography coupled with UV-detection

Tan

Ankathil

Gan

2011

Journal of Chromatography B

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Capillary electrophoresis method for plasmatic determination of imatinib mesylate in chronic myeloid leukemia patients

et al. 2011

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Imatinib (IMAT) is a tyrosine kinase inhibitor that has been used for the treatment of chronic myeloid leukemia (CML). Despite the efficacy of IMAT therapy, some cases of treatment resistance have been described in CML. Developing a plasma method is important since there are several studies that provided a higher correlation between IMAT plasma concentration and response to treatment. Therefore, in this investigation we validated a method by CE as an alternative, new, simple and fast electrophoretic method for IMAT determination in human plasma. The analysis was performed using a fused silica capillary (50 μm id×46.5 cm total length, 38.0 cm effective length); 50 mmol/L sodium phosphate buffer, pH 2.5, as BGE; hydrodynamic injection time of 20 s (50 mbar); voltage of 30 kV; capillary temperature of 35°C and detection at 200 nm. Plasma samples pre-treatment involved liquid-liquid extraction with methyl-tert-butyl ether as the extracting solvent. The method was linear from 0.125 to 5.00 μg/mL. The LOQ was 0.125 μg/mL. Mean absolute recovery of IMAT was 67%. The method showed to be precise and accurate with RSD and relative error values lower than 15%. Furthermore, the application of the method was performed in the analysis of plasma samples from CML patients undergoing treatment with IMAT.

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Validation of an HPLC Method for the Determination of Imatinib Mesylate in Pharmaceutical Dosage

Cited by 8 publications

References 6 publications

Validation of Assay Indicating Method Development of Imatinib in Bulk and Its Capsule Dosage Form by Liquid Chromatography

Validation of Assay Indicating Method Development of Imatinib in Bulk and Its Capsule Dosage Form by Liquid Chromatography

Method development and validation for the simultaneous determination of imatinib mesylate and N-desmethyl imatinib using rapid resolution high performance liquid chromatography coupled with UV-detection

Capillary electrophoresis method for plasmatic determination of imatinib mesylate in chronic myeloid leukemia patients

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