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

H.-G. Lou; Z.-R. Ruan; B. Jiang

doi:10.1055/s-0031-1297983

Arzneimittelforschung, Table of Contents

Arzneimittelforschung 2012; 62(02): 99-104
DOI: 10.1055/s-0031-1297983

Original Article

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

Authors

H.-G. Lou

¹Division of Clinical Pharmacology, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, P. R. China
Z.-R. Ruan

¹Division of Clinical Pharmacology, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, P. R. China
B. Jiang

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

Full Text

References

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