Development and validation of a LC-MS/MS method for quantitation of paroxetin in human plasma

Hoang Tran, Ngoc Cuong Cao, Thi Cham Nguyen, Phuc Chieu Tran, Lam Hong Nguyen, Minh Hien Do, Van Duc Hoang

Main Article Content

Abstract

A fast, simple, high throughput and specific method using ultra performance liquid chromatography tandem mass spectrometry was developed for quantitation of paroxetine in human plasma. The Waters Xevo TQD UPLC-MS/MS was operated under the multi reaction-monitoring mode (MRM 330.1>>192.1 for paroxetine và MRM 334.1>>196.1 for paroxetine-d4) using positive electrospray ionization technique. Paroxetine and internal standard – paroxetine-d4 were extracted from human plasma by liquid-liquid extraction. The samples were chromatographed on a C18 column (dimention 50 x 3 mm, particle 2.5 µm) at a flow rate of 0.2 mL/min using 20 mM ammonium formate solution – acetonitrile at ratio of 15 : 85. The calibration curves were found to be linear in the range 0.05 to 20 ng/mL, with mean correlation coefficient of > 0.999. The accuracy was within 85% – 115.0% and the precision was less than 15%. Total run time was 2.5 min. This method can be used for BA-BE studies of paroxetine preparations.

Article Details

References

1. Hội đồng Dược thư quốc gia Việt Nam. Dược thư quốc gia Việt Nam (2022), lần xuất bản thứ ba, Nhà xuất bản Khoa học và kỹ thuật, trang 1275-1277.
2. Massaroti P, Cassiano NM, Duarte LF, Campos DR, Marchioretto MA, Bernasconi G, Calafatti S, Barros FA, Meurer EC, Pedrazzoli J. Validation of a selective method for determination of paroxetine in human plasma by LC-MS/MS. J Pharm Pharm Sci. 2005 Aug 17;8(2):340-7. PMID: 16124946.
3. Jhee Ok; Seo HK; Lee MH; Jeon YC; Shaw LM; Lee SH; Hur Y; Kim KH; Lee HS; Lee SE; Kang JS (2011). Determination of Paroxetine in Plasma by Liquid Chromatography Coupled to Tandem Mass Spectrometry for Pharmacokinetic and Bio equivalence Studies. Arzneimittelforschung, 57(7), 455–461. Doi:10.1055/s-0031-1296631
4. U.S. Department of Health and Human Services Food and Drug Administration: Draft Guidance on Paroxetine Hydrochloride. October 2024
5. U.S. Department of Health and Human Services Food and Drug Administration (2018). Guidance for Industry - Bioanalytical Method Validation.
6. European Medicines Agency, Committee for Medicinal Products for Human Use (2012). Guideline on Validation of Bioanalytical Methods.
7. Chi J, Kim MY, Li F (2019) Quantitation of Paroxetine in Human Plasma by LC-MS/MS: Overcoming Significant Column-toColumn Retention Time Variation. J Chromatogr Sep Tech 10: 419. Doi:10.4172/2157-7064.1000419
8. Hiten J Shah, Mohan L Kundlik, Abhijit Kakad, Nitesh K Patel, Ankit Pandya, Vanita Khatri, Shivkumat Prajapati, Gunta Subbaiah, Chhagan N Patel, Quantification of Paroxetine in Human Plasma by Liquid Chromatography Coupled with Electrospray Ionization Tandem Mass Spectrometry, Journal of AOAC INTERNATIONAL. https://doi.org/10.1093/jaoac/93.1.141
9. Wang M, Zhou WJ, Zhang QY, Huang M. (2013). Development and Validation of a LC–MS/MS Method. Advanced Materials Research. Doi: 10.4028/www.scientific.net/AMR.722.255.
10. López-Calull C, Dominguez N, Determination of paroxetine in plasma by high-performance liquid chromatography for bioequivalence studies, Journal of Chromatography B: Biomedical Sciences and Applications, ISSN 0378-4347. https://doi. org/10.1016/S0378-4347(98)