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Response Surface Methodology as a Tool for Stability-Indicating Method Development and Validation for the Determination of Selective EZH2 Inhibitor

1, 2, 2, 3, 1

  1. 1Department of Pharmaceutical Sciences, Babasaheb Bhimrao Ambedkar University, Lucknow, Uttar Pradesh, INDIA.
  2. 2Department of Pharmaceutical Analysis, College of Pharmaceutical Sciences, Acharya Nagarjuna University, Guntur, Andhra Pradesh, INDIA.
  3. 3Department of Pharmacy, Central University of Rajasthan, Ajmer, Rajasthan, INDIA.

CORRESPONDENCE

Dr. Srujani Chimpiri

Department of Pharmaceutical Sciences, School of Pharmaceutical Sciences, Babasaheb Bhimrao Ambedkar University, Lucknow-226025, Uttar Pradesh, INDIA.

srujani_dewdrops@yahoo.in

Received: 06-06-2023; Revised: 14-04-2024; Accepted: 23-12-2024.

Volume 59, Issue 2s (Supplement) · pp. s705-s715 · 2025 · DOI: 10.5530/ijper.20254323

ABSTRACT

Background: Tazemetostat (TZST) is an efficient first-in-class, selective, EZH2 oral inhibitor which had demonstrated tumor regression and favourable safety in patients with Epithelioid Sarcoma. Methods developed using Analytical Quality by Design (AQbD) are highly robust, cost effective, uses good experimental designs, have shorter run times, optimization can be done by statistical analysis and can be easily validated.Objectives: The objective of the present study was to use the Screening designs for selection of initial chromatographic conditions and Response Surface Methodology (RSM) for development of optimized method based on desirability functions approach and validate sthe developed method as per ICH guidelines.Materials and Methods: To select the column, organic modifier and buffer, a 23 Factorial design was used initially for the experimental plans which majorly affect selectivity. Optimization of the method was done using Central Composite Design (CCD) under RSM.Results: Design-Expert software was used for statistical analysis of responses from CCD experimental data using ANOVA and multiple regression analysis. The set of CMP’s which shows a maximum composite desirability was taken as optimized chromatographic conditions and evaluated for the responses.Conclusion: The present work successfully demonstrated the use of AQbD approach for developing and validating stability-indicating RP-HPLC method for determination of TZST.

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    Chimpiri, S., Rani, D., Shaik, M., Desavathu, M., & Gupta, A. (2025). Response Surface Methodology as a Tool for Stability-Indicating Method Development and Validation for the Determination of Selective EZH2 Inhibitor. Indian Journal of Pharmaceutical Education and Research, 59(2s), s705-s715. https://doi.org/10.5530/ijper.20254323

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    © 2025 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. CC BY 4.0