Separation and Determination of Process-Related Impurities of Erlotinib Using Reverse-Phase HPLC with a Photo-Diode Array Detector

Karunakara, Chandrashekara; Aparna, Udupi; Chandregowda, Venkateshappa; Reddy, Chandrasekara G.

doi:10.2116/analsci.28.305

Cited by 16 publications

(7 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A c c e p t e d M a n u s c r i p t 3 The attempts were made to determine processes related impurities and development of stability indicating method of ERLO [11][12] . No study so far has been reported on the systematic approach towards characterization of degradation products of erlotinib hydrochloride under stress conditions prescribed by ICH Q1A (R2) [36] .…”

Section: Downloaded By [Nipissing University] At 01:40 20 October 2014mentioning

confidence: 99%

Separation, Identification, and Characterization of Degradation Products of Erlotinib Hydrochloride Under ICH-Recommended Stress Conditions by LC, LC-MS/TOF

Mahajan¹,

Miniyar²,

Patil³

et al. 2014

Journal of Liquid Chromatography & Related Technologies

View full text Add to dashboard Cite

Section: Downloaded By [Nipissing University] At 01:40 20 October 2014mentioning

confidence: 99%

Separation, Identification, and Characterization of Degradation Products of Erlotinib Hydrochloride Under ICH-Recommended Stress Conditions by LC, LC-MS/TOF

Mahajan¹,

Miniyar²,

Patil³

et al. 2014

Journal of Liquid Chromatography & Related Technologies

View full text Add to dashboard Cite

“…Literature survey reveals that several analytical methods are available for determination of Erlotinib hydrochloride through spectrophotometric methods (Padmalatha et al, 2011;Rajesh et al, 2011), through HPLC (Karunakara et al, 2012;Faivre et al, 2012;Chakravarthy et al, 2011;Xu et al,2011;Paez et al,2004;Nageswari et al, 2011;Ravi Kumar et al, 2013;Latha et al, 2013;Soheila et al, 2013;Geetha et al,2012;Pujeri et al, 2009;Naveen kumat et al, 2012;Chahbouni et al, 2009) in bulk drug and dosage form and through LC-MS studies (Satheeshmanikandan et al, 2012;Rivory et al, 2001;Raju et al, 2013;Andrea et al, 2007) in biological matrix. Karunakara et al (2012) presented a paper for the quantification of process impurities in Erlotinib hydrochloride active pharmaceutical ingredient. But they did not perform any degradation studies.…”

Section: Introductionmentioning

confidence: 99%

Detection of BCR-ABL gene in Chronic Myeloid Leukemia patients treated with Tyrosine Kinase Inhibitors Drugs by Gene Expert System

Khaleq

Saheb

Sultan

et al. 2018

Int. J. Res. Ph. Sci.

View full text Add to dashboard Cite

Chronic myeloid leukemia (CML) is one of human malignancies caused by genetic mutation and chromosomal translocation, a BCR-ABL fusion gene and as result Philadelphia chromosome is formed. The irregular tyrosine kinase activity of encoded protein by this gene causes the establishment of the disease. Nilotinib are potent and well inhibitor for BCR-ABL tyrosine kinase. This study was conducted at the period from September 2016 to February 2017,100 Iraqi CML patients were divided into two groups, first group of 50 patients were received Imatinib 400-800 mg/day, second group of another 50 patients were received 800 mg/day Nilotinib, WBC were microscopically counted using improved Neubauer ruled hemocytometer counting chamber.BCR-ABL gene RNA transcript and endogenous control (house keeping gene ) RNA transcript were extracted and purified and then reverse transcripted to cDNA after that the product was amplified and quantified by q RT-PCR. The results first group patients distribution according to the gender were 56% and 44% for males and females respectively while the mean age of the patients was 45.82 ± 16.17,the result of WBC counting of this group in regard to disease duration showed that the highest value was observed in newly diagnosed and advanced stage 98.28 ± 89.28,77.11± 2.98 respectively.The WBC count return to normal level after the period of treatment with Imatinib with significant reduction after one year at p≤ 0.0001.The results of molecular technique and BCR-ABL analysis in newly diagnosed, advanced stage and cytogenetic failure patients were 10.05 ± 4.7,3.03± 0.94 and 28.4±0.09 respectively with significant decrease after one year of treatment at p ≤ 0.002.On the other hand the results of the second group of CML patients in relation to the gender were 45% and 55% of males and femalesrespectively,while the mean age group was 36.68 ±13.51. The results of WBC count according to disease distribution in newly diagnosed and advanced stage were 87.5 ± 8.71 and43±21.72 respectively. WBC count was return to normal level after one year of treatment with Nilotinib with significant decrease at p≤0.0001. While the molecular technique and BCR-ABL analysis in newly diagnosed, advanced stage and cytogenetic failure group were 7.77±4, 1, 16.17 ± 3.78 and 2.02±0.53 after one year of treatment with Nilotinib with significant decrease at p≤ 0.0001. We conclude that treatment with Imatinib was found tough in a high extent of patients, Nilotinib is extending specific tyrosine kinaseinhibitor possess greater and selectively activity for BCR-ABL.

show abstract

“…[3,4] As per Literature there is no single method available for the determination of all impurities in a single method. [5][6][7] It is felt necessary to develop a stability indicating method for ERL related impurities in API and tablet dosage formulation by ICH approach.…”

Section: Introductionmentioning

confidence: 99%

Validation of High Performance Liquid Chromatography (Hplc) Method for Determination of Erlotinib Related Substance in Pharmaceutical Dosage Form

Hasin¹

2017

WJPR

View full text Add to dashboard Cite

show abstract

Separation and Determination of Process-Related Impurities of Erlotinib Using Reverse-Phase HPLC with a Photo-Diode Array Detector

Cited by 16 publications

References 9 publications

Separation, Identification, and Characterization of Degradation Products of Erlotinib Hydrochloride Under ICH-Recommended Stress Conditions by LC, LC-MS/TOF

Separation, Identification, and Characterization of Degradation Products of Erlotinib Hydrochloride Under ICH-Recommended Stress Conditions by LC, LC-MS/TOF

Detection of BCR-ABL gene in Chronic Myeloid Leukemia patients treated with Tyrosine Kinase Inhibitors Drugs by Gene Expert System

Validation of High Performance Liquid Chromatography (Hplc) Method for Determination of Erlotinib Related Substance in Pharmaceutical Dosage Form

Contact Info

Product

Resources

About