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INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016 Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI) |
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| Paper Title: | “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” |
| Authors Name: | 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 |
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IJNRD_206980
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| Published Paper Id: | IJNRD2310186 |
| Published In: | Volume 8 Issue 10, October-2023 |
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| Abstract: | 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. |
| Keywords: | Irinotecan HCL, UV-Spectrophotometric, USP, AUC, ICH-guidlience. |
| Cite Article: | "“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 (www.ijnrd.org), ISSN:2456-4184, Vol.8, Issue 10, page no.b788-b799, October-2023, Available :http://www.ijnrd.org/papers/IJNRD2310186.pdf |
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2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016 An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator |
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Published Paper ID:IJNRD2310186 Registration ID: 206980 Published In: Volume 8 Issue 10, October-2023 DOI (Digital Object Identifier): Page No: b788-b799 Country: MANDYA, KARNATAKA, INDIA Research Area: Chemistry Publisher : IJ Publication Published Paper URL : https://www.ijnrd.org/viewpaperforall?paper=IJNRD2310186 Published Paper PDF: https://www.ijnrd.org/papers/IJNRD2310186 |
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ISSN: 2456-4184
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