“A NOVEL ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF IRINOTECAN HCL TRIHYDRATE USP IN BULK AND PHARMACEUTICAL INJECTION DOSAGE FORM BY USING AREA UNDER CURVE UV- SPECTROPHOTOMETRIC METHOD”

Registration ID: IJNRD_206980

Published ID: IJNRD2310186

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Dr. PRAMILA T, Ms. GAGANA ARADHYA, Mr. MANJUNATHA M T, Ms. CHINMAYI T R, Mr. KARTHIK B B,Ms. ARLET ANTONY,Mr. APPU C M

Irinotecan HCL, UV-Spectrophotometric, USP, AUC, ICH-guidlience.

A novel, simple Area under curve UV-spectrophotometric method was developed and validated for the estimation of Irinotecan HCL Trihydrate USP in bulk and pharmaceutical Injection dosage form. The developed analytical method employs the measurement of the AUC at an absorption maximum (λmax) within the range of 216-226nm by using 99% AR grade methanol as a solvent. And obeys the beer’s law in the concentration range of 10-50µg/ml. The method exhibits excellent linearity, reproducibility, and precision in the concentration range of 10-50µg/ml with a high correlation coefficient(r2) of 0.9999 as described by the regression equation Y= 0.193X +0.001. The method accuracy is expressed interms of % recovery. The % recovery of Irinotecan HCL was found to be in the range of 99.46 – 99.88%, these obtained range values indicates the developed method is accurate. The LOQ and LOD for estimation of Irinotecan HCL was found to be 0.170µg/ml and 0.518µg/ml respectively. The %RSD values were found to be < 2%. The present developed Area under curve UV-spectrophotometric method was accomplishing the validation parameters according to ICH guidliencess for Specificity, Range, linearity, accuracy, precision, LOD, LOQ and Ruggerdness. The developed method is simple, highly accurate, novel and sucessfully applied for the analytical method development of Irinotecan HCL trihydrate USP in bulk and pharmaceutical Injection dosage form.

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Dr. PRAMILA T, Ms. GAGANA ARADHYA, Mr. MANJUNATHA M T, Ms. CHINMAYI T R, & Mr. KARTHIK B B,Ms. ARLET ANTONY,Mr. APPU C M (October-2023). “A NOVEL ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF IRINOTECAN HCL TRIHYDRATE USP IN BULK AND PHARMACEUTICAL INJECTION DOSAGE FORM BY USING AREA UNDER CURVE UV- SPECTROPHOTOMETRIC METHOD”. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 8(10), b788-b799. https://ijnrd.org/papers/IJNRD2310186.pdf

Volume 8 Issue 10, October-2023

Pages : b788-b799

Paper Reg. ID: IJNRD_206980

Published Paper Id: IJNRD2310186

Research Area: Chemistry

Author Type: Indian Author

Country: MANDYA, KARNATAKA, INDIA

Published Paper PDF: https://ijnrd.org/papers/IJNRD2310186.pdf

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