EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

European Journal of Pharmaceutical and Medical Research (EJPMR) has indexed with various reputed international bodies like : Google Scholar , Indian Science Publications , InfoBase Index (In Process) , SOCOLAR, China , Research Bible, Fuchu, Tokyo. JAPAN , International Society for Research activity (ISRA) , Scientific Indexing Services (SIS) , Polish Scholarly Bibliography , Global Impact Factor (GIF) (Under Process) , Universal Impact Factor , International Scientific Indexing (ISI), UAE , Index Copernicus , CAS (A Division of American Chemical Society) USA (Under Process) , Directory of Open Access Journal (DOAJ, Sweden, in process) , UDLedge Science Citation Index , CiteFactor , Directory Of Research Journal Indexing (DRJI) , Indian citation Index (ICI) , Journal Index (JI, Under Process) , Directory of abstract indexing for Journals (DAIJ) , Open Access Journals (Under Process) , Impact Factor Services For International Journals (IFSIJ) , Cosmos Impact Factor , Jour Informatics (Under Process) , Eurasian Scientific Journal Index (ESJI) , International Innovative Journal Impact Factor (IIJIF) , Science Library Index, Dubai, United Arab Emirates , Pubmed Database [NLM ID: 101669306] (Under Process) , IP Indexing (IP Value 2.40) , Web of Science Group (Under Process) , Directory of Research Journals Indexing , Scholar Article Journal Index (SAJI) , International Scientific Indexing ( ISI ) , Scope Database , Academia ,

ISSN 2394-3211

Impact Factor: 7.065

ICV - 79.57

Abstract

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.

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