Optimization and validation of a high-performance liquid chromatographic method with UV detection for the determination of pyrrole–imidazole polyamides in rat plasma

Fukasawa, Akiko; Nagashima, Takashi; Aoyama, T.; Fukuda, Noboru; Matsuda, Hiroyuki; Ueno, Takayoshi; Sugiyama, Hiroshi; Nagase, Hiroki; Matsumoto, Yoshiaki

doi:10.1016/j.jchromb.2007.09.032

Cited by 10 publications

(15 citation statements)

References 7 publications

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“…1A. 3,9) The equations used to describe the disposition of PyIm polyamide 1035 after intravenous administration are (1) (2) (3) (4) where X and V are the amount and volume of distribution in the corresponding compartments designated by the subscripts C, P, U, and B representing central, peripheral, urine, and bile compartments, CL D is distribution clearance, CL R is renal clearance, CL ext is clearance except renal and biliary clearance, V MAX is maximum velocity for excretion into bile, and K m is Michaelis constant for excretion into bile. The plasma concentration of Py-Im polyamide 1035 is defined as…”

Section: )mentioning

confidence: 99%

“…12) To obtain 2.5th, 50th, and 97.5th percentiles of the model estimations, 10000 simulations were performed using the estimated model parameters, variability in the estimated parameters, and residual variability of the data. The plasma concentration-time profiles of Py-Im polyamides 1035 and 1666 were obtained from the study of Fukasawa et al 4) The excluded plasma concentrations below LLOQ have been shown to adversely affect the bias and precision of parameter estimates. 1,2) The detected concentration below LLOQ of HPLC method was used in the PK modeling.…”

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confidence: 99%

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Pharmacokinetic Modeling and Prediction of Plasma Pyrrole-Imidazole Polyamide Concentration in Rats Using Simultaneous Urinary and Biliary Excretion Data

Nagashima

Aoyama

Yokoe

et al. 2009

Biological & Pharmaceutical Bulletin

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Pharmacokinetic (PK) modeling has been proposed as a means to improve the efficiency of drug development. It is difficult to develop an appropriate pharmacokinetic model if the lower limit of quantification (LLOQ) of the assay of the plasma drug concentration is high. The mathematical method of determining the plasma drug concentration below the LLOQ was discussed previously. 1,2) The method of analyzing the data including the urine concentration to construct the PK model that cannot be constructed using only plasma concentration data has also been reported.3) Not only the plasma concentration data but also urine and bile data collected over time provided information that was used as basis for the development of a PK model. Although the use of serum or plasma concentration-time profiles was primarily recommended, the use of urinary and/or biliary excretion data was regarded as an alternative approach if the bioanalytical method lacked the appropriate sensitivity to adequately characterize the serum or plasma concentration-time profile. This approach is considered to be used for the analysis of plasma concentration-time profile under LLOQ of various analytical instruments.The purpose of this study was to develop a PK model that describes the plasma concentration profiles under LLOQ of HPLC using urinary and biliary excretion data, and we used pyrrole (Py)-imidazole (Im) polyamides as model compounds. MATERIALS AND METHODS Chemicals and ReagentsThe Py-Im polyamides 1035 and 1666 reported previously 4) were purchased from Gentier Biosystems Co., Ltd. (Kyoto, Japan). Py-Im polyamide 1035 is composed of Ac-ImPyPy-g-ImPyPy-b-Dp (b: b-alanine, Dp: N,N-dimethylaminopropylamine, g: g-butyric acid), and Py-Im polyamide 1666, with a higher molecular weight, is composed of Ac-PyPy-b-PyImPy-g-PyPyPy-b-ImPy-b-Dp. The molecular weights of Py-Im polyamides 1035 and 1666 calculated on the basis of standard atomic weights 5) are 1035.12 and 1665.78, respectively. HPLC-grade methanol, acetonitrile, and distilled water were purchased from Kanto Chemical Co., Inc. (Tokyo, Japan). Midazolam and all other reagents of the highest quality were purchased from Wako Pure Chemical Industries, Ltd. (Tokyo, Japan). Pooled rat liver microsomes, pooled human liver microsomes, reduced nicotinamide adenine dinucleotide phosphate (NADPH) regenerating system solution, 1Ј-hydroxymidazolam, and 4-hydroxymidazolam were purchased from BD Bioscience (Woburn, MA, U.S.A.).Analysis of Py-Im Polyamides Unchanged Py-Im polyamides 1035 and 1666 were extracted from rat urine and bile by solid-phase extraction using Oasis ® WCX and MAX cartridges with both reverse-phase and ion-exchange sorbents. The HPLC method was based on a previous report with minor modification.4) The quantitative analyses of PyIm polyamides 1035 and 1666 including the preparation procedure have been validated using the criteria of the Food and The use of urinary and/or biliary excretion data was considered as an alternative approach if the bioanalytical method lacked the appropriate sensi...

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Section: )mentioning

confidence: 99%

Pharmacokinetic Modeling and Prediction of Plasma Pyrrole-Imidazole Polyamide Concentration in Rats Using Simultaneous Urinary and Biliary Excretion Data

Nagashima

Aoyama

Yokoe

et al. 2009

Biological & Pharmaceutical Bulletin

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“…The peak shapes were satisfactory and completely resolved from one another. No interference from rat matrices was observed (Fukasawa et al, 2007). Table 1 shows the intra-and inter-assay precision and accuracy of PI polyamides A and B.…”

Section: Bioanalyticsmentioning

confidence: 99%

“…The LLOQ was determined as 1 µg/mL for both PI polyamides A and B. All of the methods were successfully applied to evaluate the pharmacokinetics of the PI polyamides (Fukasawa et al, 2009;Fukasawa et al, 2007;Nagashima et al, 2009b Intra-assay Inter-assay Matrix Table 1. Intra-and inter-assay accuracy and precision for the determination of PI polyamides A and B in rat plasma and urine.…”

Section: Bioanalyticsmentioning

confidence: 99%

Pyrrole-Imidazole Polyamides for Gene Therapy: Bioanalytical Methods and Pharmacokinetics

Kamei¹,

Aoyama²,

Ueno³

et al. 2011

Non-Viral Gene Therapy

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“…For these large compounds, a determination method is required. The measurement of Py-Im polyamides of large molecular weight was developed and validated by high-performance liquid chromatography (HPLC) [6]. This method was applicable to pharmacokinetic study.…”

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confidence: 99%

Determination of pyrrole–imidazole polyamide in rat plasma by liquid chromatography–tandem mass spectrometry

Nagashima

Aoyama

Fukasawa

et al. 2009

Journal of Chromatography B

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Optimization and validation of a high-performance liquid chromatographic method with UV detection for the determination of pyrrole–imidazole polyamides in rat plasma

Cited by 10 publications

References 7 publications

Pharmacokinetic Modeling and Prediction of Plasma Pyrrole-Imidazole Polyamide Concentration in Rats Using Simultaneous Urinary and Biliary Excretion Data

Pharmacokinetic Modeling and Prediction of Plasma Pyrrole-Imidazole Polyamide Concentration in Rats Using Simultaneous Urinary and Biliary Excretion Data

Pyrrole-Imidazole Polyamides for Gene Therapy: Bioanalytical Methods and Pharmacokinetics

Determination of pyrrole–imidazole polyamide in rat plasma by liquid chromatography–tandem mass spectrometry

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