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
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Published Paper Details
Paper Title:
METHOD DEVELOPMENT, VALIDATION AND FORCE DEGRADATION STUDY OF EMTRICITABINE AND TENOFOVIR ALAFENAMIDE IN THEIR PHARMACEUTICAL DOSAGE FORMS USING LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY
Authors Name:
KOMAL SUTARIA
, BHAVDIP HIRAPARA , Dr. UNNATI NAIK , Dr. DIVYA BUHA
A study has been conducted to develop and validate a rapid and highly selective stability-indicating LC-MS/MS method, and to identify a degradation product for Emtricitabine and Tenofovir alafenamide. Emtricitabine and Tenofovir alafenamide are nucleoside reverse transcriptase inhibitors (NRTIs) used to treat HIV infection in adults and children.Shimadzu LC-20 AT equipped with mass spectrometer ABScix API 200 was used for LC-MS/MS. The chromatographic analysis were performed on Agilent, Zorbax, C18 (150mm x 4.6mm, 5µm) column using 10mM ammonium acetate buffer in water having pH 5.0 and Methanol (50:50, v/v) as a mobile phase. The flow rate was kept at 1 mL/min with a short run time of 10 minutes and the sample injection volume was 20 μL. MRM scans have been performed for m/z products 248.300 (daughter ion 130.000) for Emtricitabine and 477.200 (daughter ion 346.500) for Tenofovir alafenamide. A force degradation study has been performed using LC-MS for Emtricitabine and Tenofovir alafenamide at different stress levels(acidic, alkaline, oxidative, photolytic and thermal) to demonstrate the stability-indicating ability of the developed LC-MS/MS method. Emtricitabine and Tenofovir alafenamide were unstable in acidic, basic as well as oxidation conditions whereas stable in thermal and photo-degradation conditions. The developed method is validated as per ICH guidelines and found to be linear, precise, accurate, and robust. As a result of all the validation parameters, we can conclude that the developed method can be used for routine therapeutic drug monitoring with the desired precision and accuracy.
Keywords:
Emtricitabine, Force Degradation, Liquid chromatography-tandem mass spectrometry, Nucleoside Reverse Transcriptase Inhibitor, Tenofovir Alafenamide.
Cite Article:
"METHOD DEVELOPMENT, VALIDATION AND FORCE DEGRADATION STUDY OF EMTRICITABINE AND TENOFOVIR ALAFENAMIDE IN THEIR PHARMACEUTICAL DOSAGE FORMS USING LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.7, Issue 5, page no.1363-1384, May-2022, Available :http://www.ijnrd.org/papers/IJNRD2205182.pdf
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ISSN:
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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