Development and Validation of Cost Effective Chromatographic Techniques for Sunitinib Sonidegib Sulfamethoxazole Trimethoprim and Favipiravir Aligned with Analytical Quality By Design _AQBD Paradigms

Abstract

CHAPTER-1 newlineThis chapter describes analytical method development using QbD principles with the help of software tools such as Autochrom and DesignExpert. It also explains how AQbD contributes to the development of robust and efficient methods in line with new quality guidelines. The developed method was validated according to ICH Q2 guidelines for its intended use with the drug. This chapter also discusses further applications in bioanalytical and pharmacokinetic studies. newlineCHAPTER-2 newlineThis chapter describes, develop a quality-by-design (QbD) stability-indicating method for quantifying sonidegib (SONI) and its impurities using ultra-performance liquid chromatography (UPLC). Utilizing AutoChrom and Design-Expert software, we predicted physicochemical properties and established an analytical target profile (ATP). Stability was evaluated through forced degradation studies under oxidative, acid, base, thermal, and photolytic conditions. Degradation products were effectively separated using an Acquity BEH C18 column with a mobile phase of 0.02 M ammonium acetate buffer and acetonitrile (80:20 % v/v). The validated predictions facilitated the selection of robust chromatographic conditions, minimizing experimental trials. This method provides a reliable approach for quantifying SONI and its impurities in bulk drug substances, enhancing quality assurance in pharmaceutical production. newlineCHAPTER-3 newlineIn this chapter, a rapid liquid chromatographic assay was developed to assess the stability of sunitinib (SUN) and its impurities. High-pressure liquid chromatography (HPLC), guided by an analytical quality by design (AQbD) approach, enabled the detection of SUN-related impurities in finished oral dosage forms. The method involved using Pareto charts to evaluate analytical factors efficiently. A spiked sample was successfully separated into six known SUN impurities and several unidentified degradation products with high resolution, using a C18 column and a gradient elution.