Development and Validation of a LC–MS/MS Method

Abstract:

A simple, sensitive, selective, rapid, reproducible and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the identification and quantification of paroxetine (PAX) in human plasma,. Chromatographic separation was performed on XTerra RP18 (5 μm, 150 mm × 4.6 mm i.d.) column with mobile phase composed of 10 mM ammonium acetate containing 0.2% formic acid: methanol (30:70, v/v) at flow rate of 0.9 mL min-1. PAX and CZP were detected with proton adducts at m/z (amu) 330.1 192.1 and 327.2 270.1, in multiple reaction monitoring (MRM) positive mode. The method was validated over the concentration range of 0.05 - 30 ng mL-1. The lower limit of quantification (LLOQ) was 0.05 ng mL-1. The inter-run and intra-run precision was within 2.1-11.8% and 2.2-5.8%, respectively

• Periodical: Advanced Materials Research (Volume 722)
• Pages: 255-259
• DOI: https://doi.org/10.4028/www.scientific.net/AMR.722.255
• Online since: July 2013
• Authors: Meng Wang, Wen Jia Zhou, Quan Ying Zhang, Ming Huang
• Keywords: LC-MS/MS, Liquid-Liquid Extraction, Paroxetine

References

[1] Foglia JP, Sorisio D, Kirshner M, Pollock BG. Quantitative determination of paroxetine in plasma by high-performance liquid chromatography and ultraviolet detection. J Chromatogr B Biomed Sci Appl 1997; 693 (1): 147-51.

DOI: 10.1016/s0378-4347(97)00010-8

[2] Bourin M, Chue P, Guillon Y. Paroxetine: a review. CNS Drug Rev 2001; 7 (1): 25-47.

DOI: 10.1111/j.1527-3458.2001.tb00189.x

[3] Sindrup SH, Brøsen K, Gram LF. Pharmacokinetics of the selective serotonin reuptake inhibitor paroxetine: nonlinearity and relation to the sparteine oxidation polymorphism. Clin Pharmacol Ther 1992; 51(3):288-95.

DOI: 10.1038/clpt.1992.24

[4] Bloomer JC, Woods FR, Haddock RE, Lennard MS, Tucker GT. The role of cytochrome P4502D6 in the metabolism of paroxetine by human liver microsomes. Br J Clin Pharmacol 1992; 33 (5): 521-3.

DOI: 10.1111/j.1365-2125.1992.tb04082.x

[5] Guidance for Industry, Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), May 2001.

[6] Zhang S, Kan Q, Wen JG, Zhao J, Sheng Y, Li Y, et al. Pilot and pivotal study to evaluate the bioequivalence of two paroxetine 40 mg tablet formulations in healthy Chinese subjects. Int J Clin Pharmacol Ther 2012; 50(7): 514-23.

DOI: 10.5414/cp201661

[7] Massaroti P, Cassiano NM, Duarte LF, Campos DR, Marchioretto MAM, Bernasconi G, et al. Validation of a Selective method for Determination of Paroxetine in human plasma by LC-MS/MS. J Pharm Pharmaceut Sci 2005; 8(2): 340-7.

DOI: 10.1007/s00216-005-3227-z

[8] Zhu Z, Neirinck L. High-performance liquid chromatography-mass spectrometry method for the determination of paroxetine in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci 2002; 780(2): 295-300.

DOI: 10.1016/s1570-0232(02)00537-8

[9] Shah HJ, Kundlik ML, Kakad A, Patel NK, Pandya A, Khatri V, et al. Quantification of paroxetine in human plasma by liquid chromatography coupled with electrospray ionization tandem mass spectrometry. J AOAC Int 2010; 93(1): 141-9.

DOI: 10.1093/jaoac/93.1.141