A REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP IN BULK AND PHARMACEUTICAL DOSAGE FORM BY USING HPLC AND RP-HPLC METHOD

Gagana Aradhya, Manjunatha M.T.*, Chinmayi T. R., Arlet Antony, Appu C.M. and Karthik B.B.

ABSTRACT

Analytical method development and validation represent ongoing and autonomous tasks intertwined with research and development, quality control and quality assurance departments. The pivotal role of an analytical procedures in equivalence risk assessment underscores their contribution to establishing tailored acceptance criteria and result stability. The validation process confirms the appropriateness of analytical procedures for their designated purpose. The study explores HPLC and RP-HPLC methods for analyzing irinotecan hydrochloride trihydrate USP in bulk and pharmaceutical formulations, Parameters were defined and validated according to ICH guidelines, encompassing aspects such as solvent selection, linearity, range, precision, accuracy, robustness, specificity, LOD, LOQ and stability indicating analytical validation. The resulting methods are characterized by reproducibility, rendering them suitable for analyzing irinotecan hydrochloride trihydrate USP in both bulk and pharmaceutical forms.

Keywords: Irinotecan hydrochloride trihydrate USP, HPLC, Validation, ICH-guidlince.