A validated method for the determination of quetiapine fumarate tablets in human plasma by UPLC-MS/MSand its application to a pharmacokinetic study in healthy chinese subjects | [Pakistan Journal of Pharmaceutical Sciences • 2023]

Author(s):

1. Kaiwei Luo: Fuan Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd., Ningbo, China

2. Haiming Zhao: Fuan Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd., Ningbo, China

3. Huina Zhang: Fuan Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd., Ningbo, China

4. Lihong Huang: Fuan Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd., Ningbo, China

5. Jie Lin: Fuan Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd., Ningbo, China

6. Qunan Cheng: Fuan Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd., Ningbo, China

7. Wenjuan Yang: Tongde Hospital of Zhejiang Province, Hangzhou, China

8. Weiyong Lu: Tongde Hospital of Zhejiang Province, Hangzhou, China

9. Pingping Sun: Tongde Hospital of Zhejiang Province, Hangzhou, China

10. Tingting Lou: Tongde Hospital of Zhejiang Province, Hangzhou, China

Abstract:

A rapid, highly specific and sensitive UPLC-MS/MS method was developed for the determination of Quetiapine Fumarate, a therapeutic drug for various psychiatric disorders, in human plasma. The samples were pretreated using a protein precipitation method, followed by chromatographic separation using a column (Kinetex C18, 2.6 µm 50*2.1 mm) equipped with an ESI source and MRM mode mass spectrometer. In the validation results of the method, the analyte quetiapine showed a peak at approximately 1.0 minute and exhibited good linearity within the concentration from 2.5 to 2000ng/mL. The intra- and inter-batch precision CV% were within the range of -1.3% to 7.7% and precision of intra- and inter-batch were below 15.0%. Furthermore, this method demonstrated low matrix effects and high recovery rates. The quetiapine plasma sample solution remained stable at room temperature for 25 hours and following 4 freezethaw cycles. The prepared samples remained stable in the autosampler (The temperature control of the autosampler was 5oC) for 185 hours and after four freeze-thaw cycles at -20oC and -70oC for 40 days. The present work effectively employed this approach to investigate the pharmacokinetics of orally administered quetiapine fumarate tablets in a cohort of healthy Chinese individuals, both in a fasting state and after a meal.

Page(s): 1597-1607

DOI: 10.36721/PJPS.2023.36.5.SP.1597-1607.1

Published: Journal: Pakistan Journal of Pharmaceutical Sciences, Volume: 36, Issue: 5-S, Year: 2023

Keywords:

Validation , Quetiapine fumarate , UPLCMSMS , Pharmacokinetic

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