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INTERNATIONAL JOURNAL OF SCIENTIFIC DEVELOPMENT AND RESEARCH International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2455-2631 | Impact factor: 8.15 | ESTD Year: 2016 open access , Peer-reviewed, and Refereed Journals, Impact factor 8.15 |
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| Paper Title: | Exploring the Development and Validation of an RP-HPLC method for Selpercatinib Analysis in Human Plasma |
| Authors Name: | Rahamathulla M , Asok kumar D S , Manivannan R , Dinesh kumar A , Ragupathi S |
| Unique Id: | IJSDR2401062 |
| Published In: | Volume 9 Issue 1, January-2024 |
| Abstract: | A rapid fast, accurate, precise method was developed for estimation of selpercatinib in human plasma using darunavir as an internal standard by reversephase high perfomence liquid chromatography (RP-HPLC). The separation was carried out by Kromosil C18 (250mm x 4.6 mm, 5m), Mobile phase disodium hydrogen phosphate and methanol (55:45)V/V. The analysis performed at flow rate was maintained as 1.0 ml/min, using PDA detector wavelength at 218 nm. Column temperature was set and maintained at 300C Injection volume 10µL Run time 5.0 min for better separation and resolution. The retention time of selpercatinib was found to be 2.334mins. The recovery for selpercatinib was found to be 99.523%. The method was found to be linear between the concentration range of 150 to 6000 ng/ml (r2= 0.999). the lower limits of quantification were 150 ng/ml, which drug reach the blood plasma at the level of 150 ng/ml. The reported method validated as per ICH guidelines and found to be in a suitable range. |
| Keywords: | Selpercatinib, Darunavir, RP-HPLC, Human plasma, Bioanalytical, Method development, Validation. |
| Cite Article: | "Exploring the Development and Validation of an RP-HPLC method for Selpercatinib Analysis in Human Plasma", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.9, Issue 1, page no.422 - 432, January-2024, Available :http://www.ijsdr.org/papers/IJSDR2401062.pdf |
| Downloads: | 000338719 |
| Publication Details: | Published Paper ID: IJSDR2401062 Registration ID:209886 Published In: Volume 9 Issue 1, January-2024 DOI (Digital Object Identifier): Page No: 422 - 432 Publisher: IJSDR | www.ijsdr.org ISSN Number: 2455-2631 |
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