Analytical Method Development and Validation of Stability Indicating assay method of analysis for Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate tablets using High Performance Liquid Chromatography
| العنوان: | Analytical Method Development and Validation of Stability Indicating assay method of analysis for Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate tablets using High Performance Liquid Chromatography |
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| المؤلفون: | Gavaskar D, T. Somanathan, Tamilvanan M, Saravanan. R |
| المصدر: | Research Journal of Pharmacy and Technology. :2434-2439 |
| بيانات النشر: | A and V Publications, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Chromatography, Tenofovir, Lamivudine, Method of analysis, High-performance liquid chromatography, Method development, Time efficient, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, chemistry, 030220 oncology & carcinogenesis, Dolutegravir, Stability indicating, medicine, Pharmacology (medical), 030212 general & internal medicine, Pharmacology, Toxicology and Pharmaceutics (miscellaneous), medicine.drug |
| الوصف: | A novel, economic, simple, precise and time-efficient reverse-phase high performance liquid chromatographic (RPHPLC) method has been established for the simultaneous assay determination of Dolutegravir, Lamivudine and Tenofovir Disoproxil fumarate in tablet formulation. This research paper presents the detailed method development strategy and the outcome of validation challenges. The RPHPLC method was developed using a 150 x 4.6mm, 5µm C18 column, with a gradient mode using 0.1% (v/v) trifluoroacetic acid buffer and methanol, the detection was performed at 260nm. The method was validated for specificity, precision, linearity, accuracy, robustness and can be used in quality control during manufacture and for assessment of the stability samples of Dolutegravir/Lamivudine/Tenofovir Disoproxil fumarate tablets. Total elution time was about 5 min and equilibration time of about 2 min which allows analysis of more than 100 samples per day. The method reported in this study is compatible to mass spectrometry and is thus extremely useful for stability studies. |
| تدمد: | 0974-360X 0974-3618 |
| DOI: | 10.52711/0974-360x.2021.00428 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::b219c3f8877f6b2639b2aceb6f5e0ae3 https://doi.org/10.52711/0974-360x.2021.00428 |
| رقم الانضمام: | edsair.doi...........b219c3f8877f6b2639b2aceb6f5e0ae3 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 0974360X 09743618 |
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| DOI: | 10.52711/0974-360x.2021.00428 |