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Pharmaceutics 2018, 10(2), 41; https://doi.org/10.3390/pharmaceutics10020041

Simultaneous Determination of Procainamide and N-acetylprocainamide in Rat Plasma by Ultra-High-Pressure Liquid Chromatography Coupled with a Diode Array Detector and Its Application to a Pharmacokinetic Study in Rats

1
College of Pharmacy, Gachon University, Incheon 21936, Korea
2
College of Pharmacy, Inje University, Gimhae 50834, Korea
3
Department of Pharmaceutical Engineering, Inje University, Gimhae 50834, Korea
*
Authors to whom correspondence should be addressed.
Received: 9 March 2018 / Revised: 27 March 2018 / Accepted: 27 March 2018 / Published: 30 March 2018
(This article belongs to the Special Issue Drug Metabolism, Pharmacokinetics and Bioanalysis)
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Abstract

A simple, sensitive, and reliable reversed-phase, Ultra-High-Pressure Liquid Chromatography (UHPLC) coupled with a Diode Array Detector (DAD) method for the simultaneous determination of Procainamide (PA) and its major metabolite, N-acetylprocainamide (NAPA), in rat plasma was developed and validated. A simple deproteinization method with methanol was applied to the rat plasma samples, which were analyzed using UHPLC equipped with DAD at 280 nm, and a Synergi™ 4 µm polar, reversed-phase column using 1% acetic acid (pH 5.5) and methanol (76:24, v/v) as eluent in isocratic mode at a flow rate 0.2 mL/min. The method showed good linearity (r2 > 0.998) over the concentration range of 20–100,000 and 20–10,000 ng/mL for PA and NAPA, respectively. Intra- and inter-day accuracies ranged from 97.7 to 110.9%, and precision was <10.5% for PA and 99.7 to 109.2 and <10.5%, respectively, for NAPA. The lower limit of quantification was 20 ng/mL for both compounds. This is the first report of the UHPLC-DAD bioanalytical method for simultaneous measurement of PA and NAPA. The most obvious advantage of this method over previously reported HPLC methods is that it requires small sample and injection volumes, with a straightforward, one-step sample preparation. It overcomes the limitations of previous methods, which use large sample volume and complex sample preparation. The devised method was successfully applied to the quantification of PA and NAPA after an intravenous bolus administration of 10 mg/kg procainamide hydrochloride to rats. View Full-Text
Keywords: procainamide; N-acetylprocainamide; ultra-high-pressure liquid chromatography; rat; plasma; pharmacokinetics procainamide; N-acetylprocainamide; ultra-high-pressure liquid chromatography; rat; plasma; pharmacokinetics
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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Balla, A.; Cho, K.H.; Kim, Y.C.; Maeng, H.-J. Simultaneous Determination of Procainamide and N-acetylprocainamide in Rat Plasma by Ultra-High-Pressure Liquid Chromatography Coupled with a Diode Array Detector and Its Application to a Pharmacokinetic Study in Rats. Pharmaceutics 2018, 10, 41.

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