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Method Development and Validation for Simultaneous Estimation of Dasatinib and Erlotinib by Using RP-HPLC in Pharmaceutical Dosage Form

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Last date : 27-Aug-2021

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Method Development and Validation for Simultaneous Estimation of Dasatinib and Erlotinib by Using RP-HPLC in Pharmaceutical Dosage Form


Dara. Varun | Kumaraswamy. Gandla | R. Lalitha | M. Muralikrishna



Dara. Varun | Kumaraswamy. Gandla | R. Lalitha | M. Muralikrishna "Method Development and Validation for Simultaneous Estimation of Dasatinib and Erlotinib by Using RP-HPLC in Pharmaceutical Dosage Form" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-3, April 2021, pp.1128-1135, URL: https://www.ijtsrd.com/papers/ijtsrd41117.pdf

The present study describes a newly developed, optimized and validated isocratic RP-HPLC method for the separation of two tyrosine kinase inhibitors (Dasatinib-DST and Erlotinib-ERT) with Methyl paraben-MPB as internal standard (IS), in bulk and pharmaceutical formulations with the aid of Chemometrics, multi criteria decision making (MCDM) approach. The separation was achieved by using Phenomenex Enable C18 column (15×4.6 mm id, 5µm particle size) and PDA-UV-detection at 277nm.The range of independent variables used for the optimization were MeOH: 60-70%, pH: 2-2.5 and flow rate:0.3-0.8ml/min. The influence of these independent variables on the output responses: capacity factor of the first peak (k1), resolution (Rs) and separation (a) of the second peak and retention time (tR3) were evaluated. Using this strategy, mathematical model was defined, and response surface were derived for the separation. The coefficients of determination R2 were more than 0.9258 for all the models. The four responses were simultaneously optimized by using Derringer's desirability functions and MCDM approach. Optimum conditions chosen for assay were MeOH, 0.01mM KH2PO4 (pH 2.5±0.5) adjusted with diluted orthophosphoric acid solution (68.03:31.97v/v) and flow rate of 0.8 mL/min. Peak area ratio of the analyte and internal standard was used for the quantification of pharmaceutical formulation samples. Total chromatographic analysis time per sample was approximately 9.0 min with DST, MPB (IS) and ERT eluting with retention times of 2.7, 3.2, and 6.0 minutes respectively. The optimized assay condition was validated as per ICH guidelines and applied for the quantitative analysis Sprycel-DST tablet and Tarceva -ERT capsule.

Multi Criteria Decision Making Approach, Derringer’ desirability function, Tyrosine Kinase Inhibitors, RP- HPLC, Dasatinib and Erlotinib


IJTSRD41117
Volume-5 | Issue-3, April 2021
1128-1135
IJTSRD | www.ijtsrd.com | E-ISSN 2456-6470
Copyright © 2019 by author(s) and International Journal of Trend in Scientific Research and Development Journal. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0) (http://creativecommons.org/licenses/by/4.0)

International Journal of Trend in Scientific Research and Development - IJTSRD having online ISSN 2456-6470. IJTSRD is a leading Open Access, Peer-Reviewed International Journal which provides rapid publication of your research articles and aims to promote the theory and practice along with knowledge sharing between researchers, developers, engineers, students, and practitioners working in and around the world in many areas like Sciences, Technology, Innovation, Engineering, Agriculture, Management and many more and it is recommended by all Universities, review articles and short communications in all subjects. IJTSRD running an International Journal who are proving quality publication of peer reviewed and refereed international journals from diverse fields that emphasizes new research, development and their applications. IJTSRD provides an online access to exchange your research work, technical notes & surveying results among professionals throughout the world in e-journals. IJTSRD is a fastest growing and dynamic professional organization. The aim of this organization is to provide access not only to world class research resources, but through its professionals aim to bring in a significant transformation in the real of open access journals and online publishing.

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