Box -Behnken Design Approach to Method Development for Irinotecan Hydrochloride Trihydrate by Using RP-HPLC Method
Year: 2025
Type: article
Abstract: In this work, QbD tools have been applied for the validation and optimization of parameters for irinotecan hydrochloride using Box-Behnken design with the objective of acquiring a short retention time. The RP-HPLC method was developed using a C18 column by using a mobile phase composition of Acetonitrile and potassium dihydrogen phosphate whose pH was adjusted to 3.2 using orthophosphoric acid in the ratio of 60:40v/v. These included system suitability parameters like ambient temperature, flow rate 1.0 ± 0.2 ml/min, and an overall run time of 7 minutes. Analysis was carried out at 222 nm using PDA detector.The developed methodology was then validated according to ICH guidelines under various conditions. The retention time for Irinotecan HCl was found 2.16 min. Linearity was ranged from 40-120 µg/ml, the correlation coefficient less than 1. Stability time for both analyte and standard solution were found to be 5 days. Using this method, the minimum detectable limits LOD and LOQ could be estimated at 0.8 ng/ml and 2.0 ng/ml, respectively.
DOI: 10.13005/bpj/3113
Authors: Kumudhavalli Manni Venkatachari, Venkatraj Ramasamy
Institution: Vinayaka Missions University
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: diamond
OpenAlex ID: W4409529441