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

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