• Title/Summary/Keyword: HPLC/UV-Vis

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Bioequivalence of Traline Tablet to Zoloft® Tablet (Sertraline HCI 50 mg)

  • Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.41 no.5
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    • pp.317-322
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    • 2011
  • Sertraline HCl, (1S-cis)-4-(3, 4-dichloro-phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-l-naphthalenamine hydrochloride, is a potent and selective serotonin reuptake inhibitor which is used in the treatment of depression and obsessivecompulsive disorders. The purpose of the present study was to evaluate the bioequivalence of two sertraline HCl tablets, Traline tablet (Myungin Pharm. Co. Ltd.) and Zoloft$^{(R)}$ tablet (Pfizer Inc.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of sertraline from the two sertraline HCl formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $23.50{\pm}1.74$ years in age and $64.09{\pm}7.10\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 50 mg as sertraline HCl was orally administered, blood samples were taken at predetermined time intervals and the concentrations of sertraline in serum were determined using an online columnswitching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Zoloft$^{(R)}$ tablet, were 0.04, 3.26 and -1.29% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Traline tablet was bioequivalent to Zoloft$^{(R)}$ tablet.

Bioequivalence of Hana Loxoprofen Sodium Tablet to Dongwha Loxonin® Tablet (Loxoprofen Sodium 60 mg)

  • Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.41 no.2
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    • pp.117-123
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    • 2011
  • Loxoprofen sodium, a 2-phenylpropionate non-steroidal anti-inflammatory drug (NSAID), has marked analgesic and antipyretic activities and relatively weak gastrointestinal ulcerogenicity. The purpose of the present study was to evaluate the bioequivalence of two loxoprofen sodium tablets, Hana loxoprofen sodium tablet (Hana Pharm. Co., Ltd.) and Dongwha Loxonin$^{(R)}$ tablet (Dongwha Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of loxoprofen from the two loxoprofen sodium formulations was tested using KP IX Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $22.83{\pm}1.862$ years in age and $69.92{\pm}9.14$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 60 mg as loxoprofen sodium was orally administered, blood samples were taken at predetermined time intervals and the concentrations of loxoprofen in serum were determined using a online column-switching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC^t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Dongwha Loxonin$^{(R)}$ tablet, were 2.03, 2.99 and -9.49% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25 (e.g., log0.9831~log1.0535 and log0.9455~log1.1386 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Hana loxoprofen sodium tablet was bioequivalent to Dongwha Loxonin$^{(R)}$ tablet.

Preparation and Properties of Phytosphingosine Ascorbate with Retaining Skin Development Effects (피부 활성을 갖는 Phytosphingosine Ascorbate의 합성)

  • Min, Seok-Kee;Jin, Yong-Hoon;Park, Woo-Jung;Eom, Sang-Yong;Kim, Jong-Heon
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.30 no.2
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    • pp.167-172
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    • 2004
  • In the human skin, vitamin C (L -ascorbic acid) that is well known as the activated materials has effects that is skin anti-aging and wrinkle repair by giving impetus to collagen biosynthesis and anti-oxidation, and that is the sun screen, a wound recovering, inhibition melanogenesis and so on. In spite of its effects, vitamin C has the defects of the skin stimulation and easily oxidized instability by water, air, heat and light. For solving their matters, many investigation is advanced and its results are synthesized the various vitamin C derivatives. And yet they have not solved the unstable property of vitamin C and were still insufficient for the comparing with the effect of the pure vitamin C itself. In this study, in order to prepare vitamin C derivative of being improved the stability and to apply vitamin C effect in the skin, we prepared new vitamin C derivative, phytosphingosine ascorbate, by using phytosphingosine, one of sphingolipids, which have a distinguished skin affinity. Phytosphingosine ascorbate can be prepared as the ionic bond between amine group (-NH$_2$) of phytosphingosine and hydroxy group (-OH) of vitamin C by way of the relatively simple reaction. So the structure and properties of the synthesized phytosphingosine ascorbate was confirmed the use of elemental analysis (C 58.3 : H 9.3 : N 2.8 : O 29.5), MALDI TOF-MS (Mw=492.58), Ultraviolet spectra (268.5nm), lH NMR, FT-IR spectra, thermal analysis (m.p=l54$^{\circ}C$), HPLC and so on. And we could confirm the anti-bacterial and anti-oxidation effects. Based on these results, we could confirm to prepare a new material that was expected of both effects of vitamin C and phytosphingosine and that is improved properties of vitamin C.

Purification and Some Properties of Glutamine Synthetase lsolated from Chlorobium limicola f. thiosulfatophilum NCIB 8327 (Chlorobium limicola f. thiosulfatophilum NCIB 8327로부터 Glutamine Synthetase의 분리 및 특성분석)

  • Na, Jong-Uk;Kim, Ji-Yoon;Yoon, Hwan;Kang, Sa-Ouk
    • Korean Journal of Microbiology
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    • v.30 no.6
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    • pp.564-569
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    • 1992
  • A green sulfur bacterium, Chlorobium limicola f. thiosulfatophilum NCIB 8327, was grown in modified Pfennig's medium including glu1amate as a nitrogen source. Glutamine synthetase was isolated through a series of ultracentrifugation. DEAE-Sepharose CL-6B ion exchange chromatography. Sephacryl S-300 gel permeation chromatography, and preparative HPLC. The recovery and purification fold of the enzyme were 2% and 46.3. respectively. The isolated enzyme was homogeneous on UV-Visible spectrum and polyacrylamide gel electrophoretogram. The relative molecular mass of the native enzyme was estimated to be 280,000 by gel permeation chromatography. The enzyme consisted of ten subunits with relative similar molecular mass. 30.000. which was estimated by SDS-polyacrylamide gel electrophoresis. The optimal temperature and pH of the enzyme were $30^{\circ}C$ and 7.0. Km values were 27.9 mM for L-glutamine and 0.92 mM for hydroxylamine-HCr. The enzyme activity was inhibited by alanine. glycine. and tryptophan considerably, but was not affected by asparagine, lysine. leucine. and valine.

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Identification of C3G(cyanidin-3-glucoside) from Mulberry Fruits and Quantification with Different Varieties (오디에서 C3G(cyanidin-3-glucoside)의 분리, 동정 및 계통별 함량분석)

  • 김현복;김선림
    • Journal of Sericultural and Entomological Science
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    • v.45 no.2
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    • pp.90-95
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    • 2003
  • This study was carried out to identify of C3G (cyanidin-3-glucoside) from mulberry fruits and quantify with different varieties. C3G of mulberry fruits was extracted with 1% HCl-MeOH and purified with open column (5${\times}$90cm) which filled with Amberlite IRC-50 ion exchange resin. The $\lambda$max ranges of the purified C3G on UV/vis spectrum were 516nm and 280nm. Also, molecular weight of C3G from mulberry fruits by LC-Mass was determined as 449. From above results, we concluded that anthocyanin pigment of mulberry fruits was C3G only. The cyanidin-3-glucoside (C3G) was separated and quantified by High Performance Liquid Chromatography (HPLC) system using a Nova-Pack C$\_$18/ column. Mean content of the 35 tested accessions was 0.89%. Also fruity characteristics as well as C3G content to select the desirable mulberry varieties for the production of fruit were researched and analyzed. We selected three suitable varieties such as 'Susungppong', 'Kangsun', and 'Jeolgokchosaeng(Chungpuk)'.

Analysis of Components to Determine Illegal Premium Gasoline (가짜 고급휘발유 판정을 위한 성분 분석)

  • Lim, Young-Kwan;Kang, Byung-Seok;Lee, Bo-O-Mi;Park, So-Hwi;Park, Jang-Min;Go, Young-Hoon;Kim, Seung-Tae;Kang, Dea-Hyuk
    • Tribology and Lubricants
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    • v.37 no.6
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    • pp.232-239
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    • 2021
  • Petroleum is the most consumed energy source in Korea with a usage rate of 38.7% among the available primary energy sources. The price of liquid petroleum products in Korea includes taxes such as transportation·environment·energy tax. Thus, illegal production and distribution of liquid petroleum is widespread because of its huge price difference from that of the normal product and its tax-free nature. Generally, the illegal petroleum product is produced by mixing liquid petroleum with other similar petroleum alternatives. The two kinds of gasoline, common gasoline and premium gasoline, are being distributed in Korea. The premium gasoline is often adulterated with cheaper common gasoline that lowers the octane number of gasoline. It is possible to distinguish them with their color difference, green and yellow for different grade gasoline. However, when small volume of common gasoline is added to premium gasoline, it is difficult to determine whether premium gasoline contained common grade or not. In this study, we inspect gasoline, which is illegally produced by mixing common gasoline to premium gasoline. When the ratio of mixing common gasoline is increased, premium gasoline shows decreasing absorbance at 600 nm and 650 nm under UV-Vis spectrometer. Moreover, the detected intensity (mV·s) of green dye in high performance liquid chromatography (HPLC) was decreased by common gasoline under 0.99 correlation value. The more the common gasoline is mixed, the more olefin and naphthene are detected by gas chromatography. In addition, trimethyl pentane as octane improver, paraffin and toluene are decreased by common gasoline mixing. The findings of this study suggests that illegal petroleum can be identified by analysis of components and simulated samples.