Implementation of the QbD Approach to the Development and Validation of an Analytical Method for Alpha-beta Arteether

Abstract

Background: The development of effective, cost-effective, robust, sensitive, and specific analytical techniques for the analysis of drug(s), degradation product(s), and contaminants in dosage forms and biological samples is constantly required as part of the pharmaceutical product life-cycle. The adoption of systematic analytical development methodologies such as quality by design (QbD) is particularly advantageous for enhancing method performance since analytical method development encompasses a number of variables that are significant in explaining variability in method performance. Analytical Quality by Design (AQbD) is a standardised method to process validation that covers all aspects of an analytical procedure. It comprises determining the analytical target profile (ATP), identifying critical method parameters or variables, and selecting critical method attributes (CMAs) or qualities. Objective: Spectroscopic and chromatographic methods were developed, conferring the Quality by Design (QbD) tactic as per ICH Q8(R2) guidelines for analytical method development of α-β-arteether. Method: Understanding dependent variables, various factors, and their interaction effects through a desired series of experiments on the answers to be examined is referred to as QbD. Various variable factors were detected using the Ishikawa diagram. As a result, many essential factors for chromatography methods were investigated. A desired set of experiments on the answers to be evaluated was used to comprehend dependent variables, various factors, and their interaction effects using Design-Expert software version 13. Statistical research such fractional factorial designs and Plackett-Burman were employed for this. The QbD methodology was used to establish a durable, precise, and accurate HPLC analytical method for arteether. Result: Using Design Expert 13's statistical software, the findings of the Plackette Burman research were studied, and the influence of each parameter on the answers was analysed using an overlay plot. Mobile phase (Acetonitrile: water), column C18250nmX4.6mm, column temperature 300 οC, wavelength: 254 nm, injection volume 20l/min, run time 10 mins, detector waters 2489 UV/Visible detector, retention time 4.149 are among the critical parameters estimated for the development of an analytical method for α,β- arteether. Conclusion: The analytical method developed by the QbD approach was validated according to ICH Q2(R1) guidelines, and it was found that the developed analytical method is robust and specific.