Author(s): Henny Rochaeny, Candra Irawan, Ismail Dwi Saputro, Lintannisa Rahmatia, Nilna Izzatul Mawaddah

Email(s): lintan.journal@gmail.com

DOI: 10.52711/0974-360X.2022.00016   

Address: Henny Rochaeny1, Candra Irawan1, Ismail Dwi Saputro2, Lintannisa Rahmatia1*, Nilna Izzatul Mawaddah1 1Department of Analytical Chemistry Politeknik AKA Bogor, Bogor 16158, Indonesia.
2PT. Equilab International, Jakarta 12430, Indonesia.
*Corresponding Author

Published In:   Volume - 15,      Issue - 1,     Year - 2022


ABSTRACT:
We aimed to investigate the performance of the development method for sitagliptin quantification analysis in human plasma by Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry (UPLC-MS) using liquid-liquid extraction (LLE) and Nebivolol as internal standard (IS). The parameters of this presented validation method are selectivity, the lower limit of quantification (LLOQ), linearity, accuracy, precision with five different concentration (LLOQ, Low QC, Medium QC, High QC, Upper Limit Of Quantification (ULOQ)), Integrity of dilution, matrix effect, and test for stability. Based on this study, the multiple reaction monitoring (MRM) transitions were m/z 408,23 ? 127,02 for Sitagliptin and m/z 406,25 ? 151,06 for IS Nebivolol. The selectivity test obtained % interference of sitagliptin and IS nebivolol by (0.00 - 0.38) % and (0.04 - 0.24) %, respectively. LLOQ test obtained a concentration value of 10.32 ng/mL and % RSD (n = 5) of 5.27 %. When the Sitagliptin concentration ranged from 1 to 1000 ng/mL, the method showed strong linearity with a coefficient of correlation of 0.9991. Accuracy test obtained % differentiation of (-12.58 - 7.77) % and precision test obtained % RSD of (1.62 - 5.32) %. The dilution integrity test obtained % differentiation at 4 and 2 times dilution was -9.20 % and -9.16 %. Matrix effect and stability data were in line with the stipulated European Medicines Agency (EMA) guidelines for validating the bioanalytical method.


Cite this article:
Henny Rochaeny, Candra Irawan, Ismail Dwi Saputro, Lintannisa Rahmatia, Nilna Izzatul Mawaddah. Development and Validation of an Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry method with Liquid-Liquid Extraction for The Quantification of Sitagliptin in Human plasma using Nebivolol as Internal Standard. Research Journal of Pharmacy and Technology. 2022; 15(1):89-6. doi: 10.52711/0974-360X.2022.00016

Cite(Electronic):
Henny Rochaeny, Candra Irawan, Ismail Dwi Saputro, Lintannisa Rahmatia, Nilna Izzatul Mawaddah. Development and Validation of an Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry method with Liquid-Liquid Extraction for The Quantification of Sitagliptin in Human plasma using Nebivolol as Internal Standard. Research Journal of Pharmacy and Technology. 2022; 15(1):89-6. doi: 10.52711/0974-360X.2022.00016   Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2022-15-1-16


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