International Research Journal of Commerce , Arts and Science

 ( Online- ISSN 2319 - 9202 )     New DOI : 10.32804/CASIRJ

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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF DASATINIB FROM BULK AND TABLET

    3 Author(s):  POONAM KATMORE, SMITA KUMBHAR, AKSHATA KHADKE

Vol -  13, Issue- 1 ,         Page(s) : 11 - 19  (2022 ) DOI : https://doi.org/10.32804/CASIRJ

Abstract

A simple, accurate, precise, rapid and specific reverse phase HPLC method has been developed for the estimation of dasatinib in bulk and pharmaceutical dosage forms. The chromatographic separation was achieved on Phenomenox Kinetex XB-C18(150×4.6mm, 5µ) column. The mobile phase consisted of 0.1% trifluroacetic acid water: acetonitrile in (70:30v/v) at a flow rate 1.0ml/min. The analyte was monitored using UV at 324nm and run time was kept 10min. The column temperature was adjusted at 30ºC with injection volume 10µl. The retention time of dasatinib was 3.31min. Linearity was found to be in concentration range of 42-98µg/ml. Dasatinib was subjected to completely different stress conditions like acid, base, dry heat, hydrogen peroxide and UV checked for its suitability, specificity, stability and degradation. Results of study were valid statistically and by recovery studies. The method was validated according to the ICH guidelines with relevancy to accuracy, precision, specificity and linearity.

Madhuri M, Kumari  SL, Susmitha P, Lakshmi GY, Sahoo SK. Method development and validation of stability indicating RP-HPLC method for estimation of Dasatinib in tablet dosage form. Journal of Pharmacy Research. 2017; 11(5):419-423.
Rao KNV, Srivani P, Raja MA, Banji D, Kumar DS. Analytical method development and validation of Dasatinib in its pharmaceutical dosage form by UPLC with forced degradation studies. International Journal for Pharmaceutical Research Scholars. 2013; 2(4):221-227.
Alagar Raja. M, Swapna. M, Shirisha. V, Banji D, Rao. KNV, Kumar S. RP- HPLC method for estimation of Dasatinib in active pharmaceutical ingredient and pharmaceutical dosage form as per ICH guidelines. Asian Journal of Pharmaceutical analysis and Medicinal Chemistry. 2015; 3(3):109-116.

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