Exploring the Development and Validation of an RP-HPLC method for Selpercatinib Analysis in Human Plasma

Rahamathulla M , Asok kumar D S , Manivannan R , Dinesh kumar A , Ragupathi S

Selpercatinib, Darunavir, RP-HPLC, Human plasma, Bioanalytical, Method development, Validation.

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.

Published Paper   E-Certificate

"Exploring the Development and Validation of an RP-HPLC method for Selpercatinib Analysis in Human Plasma", IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455-2631, Vol.9, Issue 1, page no.422 - 432, January-2024, Available :https://ijsdr.org/papers/IJSDR2401062.pdf

Volume 9 Issue 1, January-2024

Pages : 422 - 432

Paper Reg. ID: IJSDR_209886

Published Paper Id: IJSDR2401062

Downloads: 000347189

Research Area: Pharmacy

Country: namakkal, tamilnadu, India

Published Paper PDF: https://ijsdr.org/papers/IJSDR2401062

Published Paper URL: https://ijsdr.org/viewpaperforall?paper=IJSDR2401062

ISSN: 2455-2631 | IMPACT FACTOR: 9.15 Calculated By Google Scholar | ESTD YEAR: 2016

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 9.15 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Publisher: IJSDR(IJ Publication) Janvi Wave

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