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Citation: HE Meilian, GUO Changchuan, LENG Jiawei, ZHANG Xunjie, XIAN Ruiqing, GONG Liping, SHI Feng, JIANG Wei. Determination of ambroxol hydrochloride in human plasma by ultra high performance liquid chromatography-tandem mass spectrometry and bioequivalence evaluation of its preparation[J]. Chinese Journal of Chromatography, ;2018, 36(11): 1099-1104. doi: 10.3724/SP.J.1123.2018.07021 shu

Determination of ambroxol hydrochloride in human plasma by ultra high performance liquid chromatography-tandem mass spectrometry and bioequivalence evaluation of its preparation

1.
School of Pharmaceutical Sciences, Shandong University, Jinan 250012, China;
2.
Shandong Institute for Food and Drug Control, Jinan 250101, China;
3.
School of Chemistry and Chemical Engineering, Shandong University, Jinan 250100, China

Received Date: 23 July 2018

Fund Project: National Natural Science Foundation of China (No. 81573606).

A rapid, simple and sensitive ultra high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) method was developed for the determination of ambroxol hydrochloride in human plasma, and bioequivalence of its preparation was evaluated. The 50 μL-plasma sample was treated with methanol for protein precipitation, while ambroxol-d5 was used as an internal standard (IS). The separation was carried out on a Waters XBridge BEH C18 column (50 mm×2.1 mm, 2.5 μm) by gradient elution at a flow rate of 0.4 mL/min, with 0.1% (v/v) formic acid aqueous solution and methanol containing 0.1% (v/v) formic acid as the mobile phases. The analyte was detected using an electrospray ionization source in positive ion multiple reaction monitoring (MRM) mode. The calibration curves were linear in the range of 2-400 ng/mL (r=0.998). The intra- and inter-run accuracies were 97.1%-108.7%, the intra- and inter-run precisions were 1.0%-5.6%. The method was applied to the determination of the plasma concentration of the six healthy subjects after the oral administration of 30 mg of test and reference preparations. The bioavailability was (102.3±14.8)%. The 90% confidence intervals of the test preparation's pharmacokinetic parameters were 80.0%-125.0% of the reference preparation's corresponding parameters. Thus, it is proved that the test preparation and reference preparation are bioequivalent.
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