"Development And Validation Of An Rp-Hplc Method For Tadalafil Quantification Utilizing A Quality By Design (Qbd) Strategy"

Abstract

A fast, straightforward, correct, and strong RP-HPLC analytical procedure based on a The Quality by Design (QbD) methodology, was developed for the examination of tadalafil in both its API and Finished Formulations. The Effective separation was achieved by chromatography by means of an Reversed-phase C18 column (X Bridge) with constant Carrier fluid composition."The chromatographic resolution employed a Carrier fluid of phosphate buffer (pH 6.8) and acetonitrile in a 60:40 (v/v) proportion." "Analysis was conducted with a photodiode array (PDA) detector at a wavelength of 284 nm, operating at a flow rate of 1.0 mL/min.".

In order to maximize the chromatographic circumstances, a Design of Experiments (DoE) strategy was applied Under the QbD methodology. The experimental design focused on two main factors: (i) independent variables, including the run rate and the proportion of acetonitrile in the Carrier fluid , and (ii) co-variables such as elution time, theoretical plates, and the tailing factor. Statistical analysis of the design was performed using techniques such as ANOVA, normal residual plots, Box-Cox plots for power transformation, perturbation plots, 3D response surface plots and contour plots.

The technique was authenticated in accord with ICH-Q2B guidelines. "These include parameters such as linearity, limits of detection and quantification, accuracy, precision, specificity, and robustness.". The findings demonstrated the technique’s straightforwardness, high sensitivity, and dependability, confirming its strong suitability for the routine evaluation of tadalafil.