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Arzneimittelforschung 2012; 62(02): 99-104
DOI: 10.1055/s-0031-1297983
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Quantitative Determination of Pidotimod in Human Plasma by Liquid Chromatography Tandem Mass Spectrometry: Application to a Bioequivalence Study

H.-G. Lou
1   Division of Clinical Pharmacology, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, P. R. China
,
Z.-R. Ruan
1   Division of Clinical Pharmacology, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, P. R. China
,
B. Jiang
› Author Affiliations
Further Information

Publication History

received 14 October 2011

accepted 23 November 2011

Publication Date:
16 February 2012 (online)

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Abstract

A highly sensitive and simple LC-MS/MS method after one-step protein precipitation was developed and validated for determination of pidotimod (CAS 121808-62-6) in human plasma using dextrophan (CAS 125-73-5) as internal standard (IS). Pidotimod and IS were separated on a YMC-ODS-AQ C18 column using 0.5% formic acid and methanol as a mobile phase at a flow rate of 0.3 mL/min. Detection was performed on positive ion mode of the transitions at 245.0→134.0 for pidotimod and 258.1→157.0 for IS by selected reaction monitoring (SRM). The assay exhibited a linear range of 0.05–10.0 µg/mL. The lower limit of quantification were 0.05 µg/mL. Validation results indicated that the accuracy as determined from quality control samples was in the range of  − 4.00–6.48%. Intra-day and inter-day precision was ≤ 8.35% and ≤ 8.00%, respectively. The developed method was successfully applied to a bioequivalence study in 20 healthy Chinese volunteers following a single oral dose of 800 mg pidotimod. The simple, inexpensive protein precipitation and high-throughput method makes it a suitable and valuable tool in the investigation of the clinical pharmacokinetics and bioequivalence.

Key words

pidotimod - CAS 121808-62-6 - LC-MS/MS - bioequivalence - pharmacokinetics
 

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