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International Journal for Research Trends and Innovation
International Peer Reviewed & Refereed Journals, Open Access Journal
ISSN Approved Journal No: 2456-3315 | Impact factor: 8.14 | ESTD Year: 2016
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Issue: March 2026
Volume 11 | Issue 3
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Impact Factor : 8.14
Issue per Year : 12
Volume Published : 11
Issue Published : 118
Article Submitted : 21574
Article Published : 8528
Total Authors : 22430
Total Reviewer : 805
Total Countries : 159
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| Paper Title: | METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF NITROSAMINE IMPURITIES IN OTESECONAZOLE CAPSULES BY USING RP HPLC |
| Authors Name: | Ramya Sree.A , Vamsi Krishna.B , Sridevi.P |
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IJRTI_207526
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| Published Paper Id: | IJRTI2511063 |
| Published In: | Volume 10 Issue 11, November-2025 |
| DOI: | |
| Abstract: | This research work outlines the advancement and verification of RP-HPLC techniques for impurity analysis in Otesecanazole using gradient elution with DIKMA Spursil C18 column, Potassium dihydrogen Orthophosphate buffer & Methanol as the mobile phase, techniques was optimized for specificity, precision, accuracy, linearity & robustness. Impurities including N-Nitroso-methylphenylamine, N-Nitrodiethylamine, N-Nitrodimethylamine were identified with calibration curves showing strong R2 =0.999. Precision, accuracy (101-122% recovery), SST parameters met all acceptance limitations. The technique also demonstrated LOD & LOQ limits, making it suitable for regular analysis of Oteseconazole and Its impurities to ensure quality and safety. |
| Keywords: | Oteseconazole, Impurities, RP-HPLC (High Performance Liquid chromatography) |
| Cite Article: | "METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF NITROSAMINE IMPURITIES IN OTESECONAZOLE CAPSULES BY USING RP HPLC", International Journal for Research Trends and Innovation (www.ijrti.org), ISSN:2455-2631, Vol.10, Issue 11, page no.a524-a534, November-2025, Available :http://www.ijrti.org/papers/IJRTI2511063.pdf |
| Downloads: | 000213 |
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2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016 An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 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: IJRTI2511063
Registration ID:207526
Published In: Volume 10 Issue 11, November-2025
DOI (Digital Object Identifier):
Page No: a524-a534 Country: -, -, India Research Area: Engineering Publisher : IJ Publication Published Paper URL : https://www.ijrti.org/viewpaperforall?paper=IJRTI2511063 Published Paper PDF: https://www.ijrti.org/papers/IJRTI2511063 |
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ISSN: 2456-3315
Impact Factor: 8.14 and ISSN APPROVED,
Journal Starting Year (ESTD) : 2016
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