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Indian Journal of Pharmaceutical Education and ResearchNOW IN
Article

Evaluation of pH Dependent Solubility and Examination of Variation in Pharmacokinetic Properties of Alectinib: A Quantitative Study by Implementing Integrated Quality by Design Approach for RP-HPLC Method Development and Optimization

Durga Deepthi Kolasani1, Mrunal Desai1, Prajakta Patil1, Jagadish Puralae Channabasavaiah1★★ Corresponding author

  1. 1Department of Pharmaceutical Chemistry, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, INDIA.

CORRESPONDENCE

Jagadish Puralae Channabasavaiah

Department of Pharmaceutical Chemistry, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, INDIA.

jagadish.pc@manipal.edu

Received: 12-01-2022; Revised: 08-06-2022; Accepted: 08-08-2022.

Volume 56, Issue 4 · pp. 1219–1225 · PUBLISHED 2022 · DOI: 10.5530/ijper.56.4.203

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ABSTRACT

Introduction: Alectinib, an anaplastic lymphoma kinase inhibitor of BCS class IV, is said to have pH-dependent solubility and is susceptible to interactions with co-prescribed acid-reducing agents. Objectives: A micro-dissolution study was performed to determine the effect of modulations in gastrointestinal pH using biorelevant media and a sensitive RP-HPLC technique was developed for quantification of alectinib in the same using quality by design approach. Materials and Methods: Analytical method was developed and optimized in accordance with box-behnken design followed by micro-dissolution experiment mimicking physiological pH shift. Results: The solubility of alectinib in FaSSGF decreased from 0.648 μg/ml to 0.270 μg/ml whereas in FaSSIF it dropped down from 0.574 μg/ml to 0.108 μg/ml at the end of the micro-dissolution experiment. This reveals that elevation of pH from 1.2 to 6.8 has no significant impact on its solubility and hence will not influence drug absorption. Conclusion: Nonetheless, the study would be useful for therapeutic medication monitoring, dose adjustment of co-administered drugs, proactively driving clinical research design, and obtaining a readout on pH liability for high-risk anticancer medications.

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    Kolasani, D. D., Desai, M., Patil, P., & Channabasavaiah, J. P. (2022). Evaluation of pH Dependent Solubility and Examination of Variation in Pharmacokinetic Properties of Alectinib: A Quantitative Study by Implementing Integrated Quality by Design Approach for RP-HPLC Method Development and Optimization. Indian Journal of Pharmaceutical Education and Research, 56(4), 1219–1225. https://doi.org/10.5530/ijper.56.4.203