eng Oriental Scientific Publishing Company Biomedical and Pharmacology Journal 0974-6242 2025-03-31 18 1 617 624 10.13005/bpj/3113 64057 article Kumudhavalli Manni Venkatachari 1 Venkatraj Ramasamy 2 Department of Pharmacognosy, Vinayaka Mission’s College of Pharmacy, Vinayak Mission’s Research Foundation (DU), Yercaud Main Road, Salem, Tamilnadu, India. Vinayaka Mission’s College of Pharmacy, Vinayak Mission’s Research Foundation (DU), Yercaud Main Road, Salem, Tamilnadu, India. 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. https://biomedpharmajournal.org/vol18no1/box-behnken-design-approach-to-method-development-for-irinotecan-hydrochloride-trihydrate-by-using-rp-hplc-method/ Box-Behnken design Irinotecan Isocratic Method validation QbD RP-HPLC