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

TL;DR

This paper validates an HPLC-UV method to quantify a new indole–thiazole compound (CS03) encapsulated in nanoparticles for drug development.

Contribution

A validated HPLC-UV method for quantifying a novel p-nitro indole–thiazole derivative (CS03) encapsulated in nanoparticles is presented.

Findings

The HPLC-UV method demonstrated selectivity, linearity, precision, and accuracy for CS03 quantification.

The method's detection and quantification limits were suitable for measuring CS03 post-encapsulation in nanoparticles.

CS03 stability was assessed in simulated pH environments and during nanoparticle encapsulation.

Abstract

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.

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