Novel HPLC Method for Determination of Process Related Impurities of Dasatinib Drug Substance
International Journal of Science and Research (IJSR)

International Journal of Science and Research (IJSR)
www.ijsr.net | Open Access | Fully Refereed | Peer Reviewed International Journal

ISSN: 2319-7064



Downloads: 128 | Weekly Hits: ⮙4

Research Paper | Pharmaceutical Science | Malaysia | Volume 6 Issue 11, November 2017

Novel HPLC Method for Determination of Process Related Impurities of Dasatinib Drug Substance

Sunil V. Lanke, Dhramveer Singh Shekhawat, Nishikumar Niture, Radhiah Che Rusli, Sajid Syed Shahnawaz

A simple and sensitive reverse phase liquid chromatography (RP-HPLC) method has been developed for the determination of process related impurities of Dasatinib drug substance. Separation was achieved with a Inertsil ODS 3V, (Make GL Sciences), 150mm x 4.6mm, particle size 5m column and buffer was prepared by dissolving 1.36g of potassium dihydrogen phosphate and 1.0g of sodium-1-octane sulphonic acid into 1000ml water, dissolve and adjust pH 6.0 with dilute potassium hydroxide solution. The flow rate was set 1ml/minute and the column temperature was 50C. UV detection was performed at 315nm and injection volume 20L with ambient sample temperature. The method is simple, rapid, and specific. The method is suitable for the determination of almost all process related impurities of Dasatinib drug substance. The method is useful for the determination of following impurities. a) KSM-01 (Key starting material 2-Amino-N- (2-chloro-6-methylphenyl) thiazole-5-carboxamide) b) DAS-01 (N- (2-Chloro-6-methylphenyl) -2-[ (6-chloro-2-methyl-4-pyrimidinyl) amino]-5 thiazole carboxamide) c) Dimer of DAS-01 d) N-Oxide dasatinib e) N-Deshydroxyethyl dasatinib f) Dimer of dasatinib drug substance

Keywords: RP-HPLC, KSM key starting material and DAS-01 Dasatinib intermediate

Edition: Volume 6 Issue 11, November 2017

Pages: 51 - 58

Share this Article

How to Cite this Article?

Sunil V. Lanke, Dhramveer Singh Shekhawat, Nishikumar Niture, Radhiah Che Rusli, Sajid Syed Shahnawaz, "Novel HPLC Method for Determination of Process Related Impurities of Dasatinib Drug Substance", International Journal of Science and Research (IJSR), https://www.ijsr.net/search_index_results_paperid.php?id=ART20177411, Volume 6 Issue 11, November 2017, 51 - 58

Enter Your Email Address and Click Download Button





Similar Articles with Keyword 'RP-HPLC'

Downloads: 95 | Weekly Hits: ⮙4 | Monthly Hits: ⮙8

Research Paper, Pharmaceutical Science, India, Volume 8 Issue 11, November 2019

Pages: 767 - 773

Stability Indicating Validated RP-HPLC Method Development for Simultaneous Estimation of Benidipine Hydrochloride and Telmisartan from Pharmaceutical Dosage Form

Varsha Chandgude, G. K. Dyade, R. B. Jadhav

Share this Article

Downloads: 116 | Weekly Hits: ⮙3 | Monthly Hits: ⮙12

Research Paper, Pharmaceutical Science, India, Volume 7 Issue 9, September 2018

Pages: 1341 - 1346

Analytical Method Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Paracetamol and Tolperisone Hydrochloride Drug in Pure and Pharmaceutical Dosage Form

Yogesh Waghmare, Sonali Mahaparale

Share this Article

Downloads: 127 | Weekly Hits: ⮙2

Research Paper, Pharmaceutical Science, India, Volume 8 Issue 12, December 2019

Pages: 1271 - 1280

Application of Quality by Design Approach for Development and Validation of Analytical RP-HPLC Method for Prasugrel HCL in Bulk and Tablet Dosage Form

Tejas Sanjay Kankariya, Sarfaraz Muzaffar Shaikh, Preeti Anantwar, Vishwadeep Madhukar Shelke, Yogita Sahebrao Ingle, Danish Mohamad Sayyad

Share this Article

Downloads: 128 | Weekly Hits: ⮙4

Research Paper, Pharmaceutical Science, Malaysia, Volume 6 Issue 11, November 2017

Pages: 51 - 58

Novel HPLC Method for Determination of Process Related Impurities of Dasatinib Drug Substance

Sunil V. Lanke, Dhramveer Singh Shekhawat, Nishikumar Niture, Radhiah Che Rusli, Sajid Syed Shahnawaz

Share this Article

Downloads: 184 | Weekly Hits: ⮙4

Research Paper, Pharmaceutical Science, India, Volume 8 Issue 10, October 2019

Pages: 184 - 190

RP - HPLC Method Development & Validation for the Simultaneous Estimation of Encorafenib and Binimetinib in API & Tablet Dosage Form

Kafiya Suroor, Kudaravalli Sreedevi

Share this Article



Top