Share This Article:

Liquid Chromatography Tandem Mass Spectrometry Method for Determination of Anti-Diabetic Drug Repaglinide in Human Plasma

Full-Text HTML Download Download as PDF (Size:1765KB) PP. 281-290
DOI: 10.4236/ajac.2014.54035    3,677 Downloads   5,445 Views  

ABSTRACT

A highly sensitive, accurate and rapid analytical method based on reversed-phase liquid chromatography/electrospray ionization tandem mass spectrometry (RP-LC-ESI-MS/MS) has been developed and validated for the determination of repaglinide in human plasma using cetirizine as an internal standard (IS). The method was validated over a linear range of 0.5 - 100 ng/ml. After addition of IS, analytes were extracted from the plasma samples by liquid-liquid extraction using tert-butyl methyl ether as. The dried residue was reconstituted with 500 μL of mobile phase consisting of water/methanol/acetonitrile (62.5:20:17.5, v/v/v) and 0.2% formic acid. Chromatographic separations were achieved on a C18 analytical column. The analytes were detected with a triple quadrupole mass spectrometer using turbo V? ion spray source with positive ionization in multiple reaction monitoring (MRM) mode using MRM transitions m/z 453.3 > 162.2 and m/z 389.0 > 201.1 for the drug and IS, respectively. The proposed method was fully validated in terms of linearity, accuracy, precision, specificity, sensitivity, recovery and stability, giving results within the acceptable range. This method was successfully applied for a large number of authentic human plasma samples from a bioequivalence study.

Conflicts of Interest

The authors declare no conflicts of interest.

Cite this paper

Fayyad, M. and Ghanem, E. (2014) Liquid Chromatography Tandem Mass Spectrometry Method for Determination of Anti-Diabetic Drug Repaglinide in Human Plasma. American Journal of Analytical Chemistry, 5, 281-290. doi: 10.4236/ajac.2014.54035.

References

[1] Heiningen, P.N.M., Hartorp, V., Nielsen, K.K., Hansen, K.T., Lier, J.J., Merbel, N.C., Oosterhuis, B. and Jonkman, J.H.G. (1999) Absorption, Metabolism and Excretion of a Single Oral Dose of 14C-Repaglinide during Repaglinide Multiple Dosing. European Journal of Clinical Pharmacology, 55, 521-525.
http://dx.doi.org/10.1007/s002280050667
[2] Sankar, D.G., Pawar, A.M., Sumanth, S.K. and Latha, P.M. (2005) Determination of Repaglinide in Pure Formulations. Asian Journal of Chemistry, 17, 2025-2027.
[3] Sankar, D.G., Pawar, A.M., Sumanth, S.K. and Latha, P.M. (2005) Determination of Repaglinide in Pharmaceutical Formulations. Asian Journal of Chemistry, 17, 2022-2024.
[4] Jain, S.K., Agrawal, G.P. and Jain, N.K. (2005) HPLC Determination of Repaglinide in Formulations Using Electro-chemical Detection. Indian Journal of Pharmaceutical Sciences, 67, 249-251.
[5] Chaudhari, B.G., Rajput, S.J., Shah, P.B. and Shri, B.M. (2005) Determination of Repaglinide in Pharmaceutical Preparations Using HPLC Followed by UV Detrection. Indian Journal of Pharmaceutical Sciences, 67, 229-231.
[6] Gandhimathi, M., Ravi, T.K. and Renu, S.K. (2003) Determination of Repaglinide in Pharmaceutical Formulations by HPLC with UV Detection. Analytical Sciences, 19, 1675-1677.
http://dx.doi.org/10.2116/analsci.19.1675
[7] Greischel, A., Beschke, K., Rapp, H. and Roth, W. (1991) Quantitation of the New Hypoglycaemic Agent AG-EE 388 ZW in Human Plasma by Automated High-Performance Liquid Chromatography with Electrochemical Detection. Journal of Chromatography B: Biomedical Sciences and Applications, 568, 246-252.
http://dx.doi.org/10.1016/0378-4347(91)80360-O
[8] Huifang, J., Lin, X., Mingjuan, Y., Lin, Z. and Xin, H. (2001) HPLC Determination of Repaglinide in Biological Samples. Zhongguo Yaoke Daxue Xuebao, 32, 30-33.
[9] Ho, E.N., Yiu, K.C., Wan, T.S., Stewart, B.D. and Watkins, K.L. (2004) Detection of Anti-Diabetics in Equine Plasma and Urine by Liquid Chromatography-Tandem Mass Spectrometry. Journal of Chromatography B, 811, 65-73.
http://dx.doi.org/10.1016/S1570-0232(04)00641-5
[10] Lee, H. (2005) Pharmaceutical Applications of Liquid Chromatography Coupled with Mass Spectrometry (LC/MS). Journal of Liquid Chromatography & Related Technologies, 28, 1161-1202.
http://dx.doi.org/10.1081/JLC-200053022
[11] US Department of Health and Human Services, Food and Drug Administration (2001) Guidance for Industry: Bioanalytical Method Validation. Center for Drug Evaluation and Research, Rockville.

  
comments powered by Disqus

Copyright © 2018 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.