• Title/Summary/Keyword: high performance liquid chromatography

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Bioequivalence of BestidineTM Tablet to Dong-A GasterTM Tablet (Famotidine 20 mg) (동아가스터 정(파모티딘 20 mg)에 대한 베스티딘 정의 생물학적동등성)

  • Park, Chang-Hun;Joung, Sun-Koung;Choi, Mee-Hee;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Hee-Joo;Lee, Kyung-Ryul
    • Journal of Pharmaceutical Investigation
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    • v.34 no.6
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    • pp.505-511
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    • 2004
  • A bioequivalence study of $Bestidine^{TM}$ tablets (Choong Wae Pharma. Corp., Korea) to Dong-A $Gaster^{TM}$ (Dong-A Pharmaceutical Co., Ltd., Korea) tablets was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the famotidine dose of 40 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of famotidine were monitored by a high-performance liquid chromatography for over a period of 12 hours after the administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the Cmax ratio for $Bestidine^{TM}/Gaster^{TM}$ were log 0.90-log 1.06 and log 0.98-log 1.20, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Bestidine^{TM}$ and $Gaster^{TM}$ with respect to the rate and extent of absorption.

Bioequivalence of Atorva Tablet® to Lipitor Tablet® (Atorvastatin 20 mg) (리피토정® (아토르바스타틴 20 mg)에 대한 아토르바정®의 생물학적동등성)

  • Lim, Hyun-Kyun;Lee, Tae-Ho;Lee, Jae-Hyun;Youm, Jeong-Rok;Song, Jin-Ho;Han, Sang-Beom
    • Journal of Pharmaceutical Investigation
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    • v.38 no.2
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    • pp.135-142
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    • 2008
  • The present study describes the evaluation of the bioequivalence of two atorvastatin tablets, Lipitor $Tablet^{(R)}$ (Pfizer, reference drug) and Atorva $Tablet^{(R)}$ (Yuhan, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Forty-nine healthy male Korean volunteers received each medicine at the atorvastatin dose of 40 mg in a $2{\times}2$ crossover study with a two weeks washout interval. After drug administration, serial blood samples were collected at a specific time interval from 0-48 hours. The plasma atorvastatin concentrations were monitored by an high performance liquid chromatography -tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction monitoring (MRM) and positive ion mode. The total chromatographic run time was 4.5 min and calibration curves were linear over the concentration range of 0.1-100 ng/mL for atorvastatin. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48hr) was calculated by the linear log trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were complied trom the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Atorva $Tablet^{(R)}$ / Lipitor $Tablet^{(R)}$ were ${\log}\;0.9413{\sim}{\log}\;1.0179$ and ${\log}\;0.831{\sim}{\log}\;1.0569$, respectively. These values were within the acceptable bioequivalence intervals of ${\log}\;0.8{\sim}{\log}\;1.25$. Based on these statistical considerations, it was concluded that the test drug, Atorva $Tablet^{(R)}$ was bioequivalent to the reference drug, Lipitor $Tablet^{(R)}$.

eRF1aMC and $Mg^{2+}$ Dependent Structure Switch of GTP Binding to eRF3 in Euplotes octocarinatus

  • Song, Li;Jia, Yu-Xin;Zhu, Wen-Si;Chai, Bao-Feng;Liang, Ai-Hua
    • Journal of Microbiology and Biotechnology
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    • v.22 no.2
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    • pp.176-183
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    • 2012
  • Eukaryotic translation termination is governed by eRF1 and eRF3. eRF1 recognizes the stop codons and then hydrolyzes peptidyl-tRNA. eRF3, which facilitates the termination process, belongs to the GTPase superfamily. In this study, the effect of the MC domain of eRF1a (eRF1aMC) on the GTPase activity of eRF3 was analyzed using fluorescence spectra and high-performance liquid chromatography. The results indicated eRF1aMC promotes the GTPase activity of eRF3, which is similar to the role of eRF1a. Furthermore, the increased affinity of eRF3 for GTP induced by eRF1aMC was dependent on the concentration of $Mg^{2+}$. Changes in the secondary structure of eRF3C after binding GTP/GDP were detected by CD spectroscopy. The results revealed changes of conformation during formation of the eRF3C GTP complex that were detected in the presence of eRF1a or eRF1aMC. The conformations of the eRF3C eRF1a GTP and eRF3C eRF1aMC GTP complexes were further altered upon the addition of $Mg^{2+}$. By contrast, there was no change in the conformation of GTP bound to free eRF3C or the eRF3C eRF1aN complex. These results suggest that alterations in the conformation of GTP bound to eRF3 is dependent on eRF1a and $Mg^{2+}$, whereas the MC domain of eRF1a is responsible for the change in the conformation of GTP bound to eRF3 in Euplotes octocarinatus.

Development of HPLC-UV method for detection and quantification of seven organic acids in animal feed (사료 중 유기산 7종 동시분석법 개발 및 유통 사료의 모니터링)

  • Kim, Jin kug;Lee, Mi Jin;Lee, Ye Ji;Kim, Hye Jin;Jeong, Min Hee;Kim, Ho Jin
    • Analytical Science and Technology
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    • v.29 no.4
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    • pp.202-208
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    • 2016
  • 본 연구에서는 사료 첨가제로 이용되고 있는 유기산 7종(formic acid, malic acid, lactic acid, acetic acid, citric acid, fumaric acid, propionic acid)의 동시분석법 개발을 위한 연구를 실시하였다. 7종의 화합물은 표준물질의 Retention time과 UV spectra를 통해 구별하였고, 분석법 검증은 직선성, 민감성, 선택성, 정확성, 정밀성을 통하여 검증하였다. 그 결과로 LOD와 LOQ의 범위가 각각 43~26,755 μg/kg, 12-8,026 μg/kg으로 설정하였고, 평균 회수율이 79.3~95.2%로 우수하게 보였으며, intra-day, inter-day에 대한 전반적인 상대 표준 편차(%RSD)는 3.2% 미만으로 나타났다. 이와 같이 검증된 자료를 통해 유기산의 동시분석에 대한 직선성, 민감성, 선택성, 정확성 및 정밀성을 확인하였고, 높은 수준을 나타냄을 알 수 있었다. 이를 바탕으로 유기산이 검출되는 단미사료 46 가지를 분석에 적용하여 진행하였고, 정량과 동시분석 검출을 위한 방법은 RP-HPLC/UV 검출기를 이용하여 성공적으로 개발되었다. 따라서 본 연구결과를 바탕으로 하여 사료 중의 유기산의 분석이 신속하고 정확해졌을 뿐 아니라, 다른 종류의 사료 또한 이를 적용하여 효율적으로 이용할 수 있을 것으로 판단된다.

Development and validation of a HPLC method for the simultaneous determination of chlorquinaldol and promestriene in complex prescription (복방제제 내 클로르퀴날돌과 프로메스트리엔에 대한 HPLC 기반 동시분석법의 개발 및 밸리데이션)

  • Lee, Seul-Ji;Shin, Sang-Yeon;Shin, Hae-Jin;Lee, Jin-Gyun;Kim, Dong-Hwan;Lee, Su-Jung;Han, Sang-Beom;Park, Jeong-Hill;Lee, Jeong-Mi;Kwon, Sung-Won
    • Analytical Science and Technology
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    • v.25 no.2
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    • pp.152-157
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    • 2012
  • Currently, many types of compound preparations are being used but the quality control guidelines for their use are lacking. In case of single compound drug, the quality control methods are specified in the pharmacopeia. However, there is no method to simultaneously analyze compound preparations. In this study, a simple validated analytical method for HPLC separation of chlorquinaldol and promestriene is introduced. Validation was divided into categories including linearity, precision, accuracy (recovery) and system suitability. The contents of the products which are on the market were monitored using the validated analytical method and the robustness of the analytical method was tested by conducting an inter-laboratory validation.

Effect of Ephedrine on the Levels of Biogenic Amines and Their Metabolites in Rat Brain (Ephedrine이 뇌내 Biogenic Amine 함량에 미치는 영향)

  • Lee, Kyung-Eun
    • The Korean Journal of Pharmacology
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    • v.31 no.2
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    • pp.153-164
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    • 1995
  • Sympathomimetic amines, especially ephedrine, are a major ingredient in proprietary medications for symptomatic treatment of upper respiratory infections. Their frequent uses can lead to occasional instances of abuse and habituation. The clinical symptoms of ephedrine abuse are similar to that of amphetamine psychosis and resemble closely that of schizophrenia. Because both amphetamine psychosis and schizophrenia are thought to be mediated primarily through the action on catecholamines, ephedrine-induced changes of the biogenic amines can be suspected. However, there were few studies about the central effects of ephedrine because of the milder central action than peripheral. Therefore, the present investigation was undertaken to elucidate the relations between the effects of single or repeated administration of ephedrine on the regional levels of biogenic amines in rat brain and ephedrine-induced CNS stimulation. The male Sprague-Dawley rats weighing $100{\sim}200\;g$ were used. After single or repeated administrations of ephedrine, blocks of tissue were obtained from frontal cortex, corpus striatum, hippocampus, thalamus, hypothalamus, substantia nigra and cerebellum. The concentration of biogenic amines(norepinephrine, epinephrine, dopamine, 5-hydroxytryptamine(5-HT)) and their metabolites (3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid(HVA), 5-hydroxyindoleacetic acid(5-HIAA)) were measured by means of high performance liquid chromatography-electrochemical detector(HPLC-ECD). The results obtained were as follows: 1) In the normal rat, the concentration of norepinephrine was the highest in hypothalamus. Dopamine, DOPAC and HVA were highest in corpus striatum, and 5-HT and 5-HIAA were highest in substantia nigra. Epinephrine was not detectable in any part of the brain tissue. 2) In a single administration of ephedrine, the concentration of DOPAC was decreased in corpus striatum. However, the other biogenic amines and their metabolites were not changed. 3) In repeated administration of ephedrine, the concentration of norepinephrine was decreased in all brain region checked. Dopamine was decreased in corpus striatum and substantia nigra and, increased in hypothalamus, and HVA was decreased in corpus striatum. 5-HT was decreased in all brain region except cerebellum and, 5-HIAA was decreased only in frontal cortex. The ratio of 5-HIAA/5-HT was increased in corpus striatum, thalamus, hypothalamus and substantia nigra. These data indicated that, although a single administration of ephedrine did not change the central neurotransmitters, repeated administration of ephedrine caused the decreases of norepinephrine and 5-HT in the most regions of brain, which may be responsible for the emergence of abnormal behavioral effect after ephedrine abuse.

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Characteristics and Action Pattern of ${\alpha}-galactosidase$ from Scopulariopsis brevicaulis in Korean Traditional Meju (한국 재래 간장에서 분리한 Scopulariopsis brevicaulis가 생성하는 ${\alpha}-galactosidase$의 특성 및 작용양상)

  • Choi, Kwang-Soo;Lee, Seon-Ho;Hong, Seung-Pyo;Lee, Hee-Duck;Bae, Du-Kyung;Choi, Cheong
    • Applied Biological Chemistry
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    • v.41 no.7
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    • pp.489-495
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    • 1998
  • The optimum culture condition of Scopulariopsis brevicaulis for the production of ${\alpha}$-galactosidase was as follows: Tryptone 1.5%, $NH_4NO_3$ 0.2%, Raffinose 2.5%, $KH_2PO_4$ 0.5%, yeast extract 0.5%, pH 7.0, $27^{\circ}C$. The optimum pH and temperature for the enzyme activity of ${\alpha}$-galactosidase producing Scopulariopsis brevicaulis were pH 7.0 and $27^{\circ}C$, respectively. The enzyme was relatively stable at $pH\;6.0{\sim}8.0$ and at temperature below $40^{\circ}C$. The activity of the enzyme was inhibited by $Ag^{2+},\;Hg^{2+},\;Cu^{2+}$, p-chloromercuribenzoic acid and Iodine. These results would indicate the presence of -SH groups in the catalytic site of the enzyme. Km value was 1.9 mM for $p-nitrophenyl-{\alpha}-D-galactopyranoside$ and Vmax value was $9.66{\times}10^2\;{\mu}M/min$. Sugar constituents of culture broth were identified by HPLC that the enzyme liberated sucrose, glucose and fructose from raffinose and raffinose was significantly decreased.

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Pharmacokinetics of Toltrazuril after Oral Administrations in Broilers (톨투라주릴의 육계에서의 약물동태학적 연구)

  • Lim, Jong-Hwan;Park, Byung-Kwon;Kim, Myoung-Seok;Hwang, Yun-Hwan;Song, In-Bae;Yun, Hyo-In
    • Journal of Veterinary Clinics
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    • v.24 no.3
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    • pp.308-311
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    • 2007
  • A study on the oral bioavailability and pharmacokinetics of an anticoccidal agent, toltrazuril, was conducted in broilers following a single oral doses of 10 mg/kg body weight (BW) or 40 mg/kg BW. The concentrations of toltrazuril in plasma were determined by a high-performance liquid chromatography/mass spectrometry. Plasma concentration-time data after single oral administration were analyzed by a non-compartmental analysis. Toltrazuril was very well-absorbed through the gastrointestinal tract with $C_{max}$ of $18.04{\pm}5.80{\mu}g/mL$ and $47.15{\pm}9.40{\mu]g/mL$ at $4.33{\pm}1.51h$ and $3.67{\pm}1.15h$ after oral dose of 10 mg/kg and 40 mg/kg in broilers, respectively. A comparison between 10 mg/kg and 40 mg/kg dose groups showed that $t_{max}$ were similar while $C_{max}$ and area under curve (AUC) increased with increasing dose.

Characterization and Antimicrobial Activity of Lactic Acid Bacteria Isolated from Vaginas of Women of Childbearing Age (가임기 여성의 질에서 분리한 젖산 세균인 Lactobacillus plantarum UK-3의 특성 및 항균활성)

  • Ahn, Hye-Ran;So, Jae-Seong;Oh, Kye-Heon
    • Korean Journal of Microbiology
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    • v.47 no.4
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    • pp.308-315
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    • 2011
  • The purpose of this work was to examine the antimicrobial activity derived from the lactic acid bacterium, UK-3 isolated from the vaginas of women of childbearing age. Various physiological and biochemical properties of this strain were characterized. Both the BIOLOG system and phylogenetic analysis using 16S rRNA sequencing were utilized for identification, and the strain was designated as Lactobacillus plantarum UK-3, and registered in GenBank as [JK266589]. Growth rate, production of organic acids (e.g., lactic acid and acetic acid), and pH during growth were monitored. The maximum concentrations of lactic acid and acetic acid were approximately 684.11 mM and 174.26 mM, respectively, and pH changed from 7.0 to 3.7 after 72 h of incubation. High performance liquid chromatography was used to confirm lactic acid and acetic acid production. Significant antimicrobial activity of the concentrated supernatant was demonstrated against various Gram-positive (e.g., Staphylococcus aureus, Staphylococcus epidermidis, Methicillin-resistant Staphylococcus aureus, Enterococcus faecalis, Neisseria species., Listeria monocytogenes), Gram-negative bacteria (e.g., Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis), and yeast (e.g., Candida albicans) by the plate diffusion method. As a result, the concentrated L. plantarum UK-3 cultures had lower acidity and inhibited the growth of all microorganisms tested, whereas the growth of L. acidophilus was not affected.

A Comparative Study of the Assay Methods Used to Quantify Fermentable Sugar in Makgeolli Sul-dut (막걸리 술덧의 발효성 당 분석방법 비교 연구)

  • Kim, Byong-Soo;Kim, Gye-Won;Shim, Jae-Yong
    • Korean Journal of Food Science and Technology
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    • v.48 no.1
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    • pp.48-53
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    • 2016
  • The objective of this study was to evaluate the accuracy and efficiency of different methods used for the fermentable sugar assay in the production of Makgeolli sul-dut. In the initial stage of fermentation, Ipguk treatment produced a higher alcohol content compared to the Nuruk treatment. However, the alcohol content was not significantly different between the two starters at the final stage of fermentation. Acidity in the Ipguk treatment was higher than that of Nuruk throughout the fermentation period. After analyzing the fermentable sugars using dinitrosalicylic acid (DNS), Fehling's method, refractometer, glucose kit, and high performance liquid chromatography (HPLC), it was confirmed that the HPLC method was the most accurate for fermentable sugar quantification. In both types of starters, DNS and Fehling's methods showed results comparable to HPLC in terms of fermentable sugar content, while the glucose kit and refractometer analyses showed relatively large discrepancies, indicating that the Fehling's method could also be effective for the analysis of fermentable sugars in the manufacture of Makgeolli.