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IJMABHR

International Journal of Medical and All Body Health Research

IJMABHR

2582-8940

Anfo Publication House

222

A new analytical novel RP-HPLC method development and validation for the quantitative determination of Dasatinib in pure form and marketed pharmaceutical dosage form

Iram

Sumera

Nuthana

Yerragolla

Shireesha

Marella

Teja

Kondoju Sai

Chary

Somoju Sairam

1Assistant Professor, Department of Pharmacy Practice, Sree Dattha Institute of Pharmacy, Sheriguda (V), Ibrahimpatnam (M), Ranga Reddy, Telangana, India 2Department of Pharmaceutical Analysis, Sree Dattha Institute of Pharmacy, Sagar Road, Sheriguda, Ibrahimpatnam, Telangana, India

2024

5 2 31 37 08032024 10042024

CC BY-NC-SA 4.0

The present work includes a simple, economic, rapid, accurate and precise isocratic RP-HPLC method development for estimation of Dasatinib in bulk form and its marketed formulation. Estimation was done at 286nm which was found to be λmax of Dasatinib. The simple, selective, isocratic RP-HPLC method for Dasatinib was developed on Phenomenex Luna (C18) RP Column; 250 mm x 4.6 mm, 5µm with a mobile phase of Phosphate Buffer (pH-4.6) and Methanol were taken in the ratio of 65:35% v/v at a flow rate of 1.0 ml/min and detection wavelength 286nm. The developed method was validated successfully according to ICH Q2 (R1) guidelines. The chromatographic methods showed a good linear response with r2 values of 0.9995. The percentage relative standard deviation for method was found to be less than two, indicating that the methods were precise. The mean percentage recovery was for RP-HPLC method was 100.437%. From the results it could be concluded that both the developed method was specific, selective and robust. The method could be successfully applied for analysis of Bulk form and Marketed formulation of Dasatinib.

DasatinibRP-HPLCMethod DevelopmentValidationICH Guidelines

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Nataraj KS, Sivalingachari P, Sai Naveen K, Alekhya K. Method Development and Validation for the Estimation of Dasatinib Monohydrate Tablets by RP-HPLC. Asian J Res Chem. 2013; 6(9):859-862. Copyright and License © The Author(s). Authors retain the copyright of their published articles. This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution Non Commercial-Share A like 4.0 International (CC BY-NC-SA 4.0) License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.