Novel Indole–Thiazole Derivative Containing a p-Nitro Substituent (CS03): Validation of an HPLC-UV Quantification Method

The validation of an analytical method enables the identification of the physicochemical characteristics of a molecule, aiding in the development of new drugs and allowing for its dosage in pharmaceutical forms. This is a crucial step in the creation of new pharmaceutical products. This article aims to validate a method for quantifying a novel indole–thiazole derivative with a p-nitro substituent (CS03) encapsulated in nanoparticles. The CS03 quantification method was evaluated using HPLC-UV techniques based on selectivity, linearity, accuracy, precision, detection and quantification limits, and robustness. Additionally, the stability of CS03 in various simulated pH environments and its encapsulation in polysaccharide-coated nanoparticles were assessed. The method proved effective in quantifying CS03, demonstrating selectivity, linearity, precision, and accuracy, with detection and quantification limits appropriate for measuring the molecule postencapsulation in nanoparticles. The validated method is suitable for determining CS03, facilitating studies focused on the clinical application of this molecule for new drug development.