METHOD DEVELOPMENT, VALIDATION AND FORCE DEGRADATION STUDY OF EMTRICITABINE AND TENOFOVIR ALAFENAMIDE IN THEIR PHARMACEUTICAL DOSAGE FORMS USING LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY

Registration ID: IJNRD_181609

Published ID: IJNRD2205182

DOI: http://doi.one/10.1729/Journal.30488

KOMAL SUTARIA , BHAVDIP HIRAPARA , Dr. UNNATI NAIK , Dr. DIVYA BUHA

Emtricitabine, Force Degradation, Liquid chromatography-tandem mass spectrometry, Nucleoside Reverse Transcriptase Inhibitor, Tenofovir Alafenamide.

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.

Published Paper   E-Certificate

KOMAL SUTARIA, BHAVDIP HIRAPARA, Dr. UNNATI NAIK, & Dr. DIVYA BUHA (May-2022). 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, 7(5), 1363-1384. http://doi.one/10.1729/Journal.30488

Volume 7 Issue 5, May-2022

Pages : 1363-1384

Paper Reg. ID: IJNRD_181609

Published Paper Id: IJNRD2205182

Downloads: 000121988

Research Area: Engineering

Country: Ahmedabad, Gujarat, India

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Crossref DOI: http://doi.one/10.1729/Journal.30488

Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)

ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016

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