• Proceedings of the Korean Society of Food Hygiene and Safety Conference
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• 2001.10a
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• pp.54-60
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• 2001

• Proceedings of the PSK Conference
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• 2003.10b
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• pp.219.2-219.2
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• 2003

We want to actively cope with technological developments by improving our drug specification in Korean Pharmaceutical Codex. Pheniramine maleate and naphazoline HCl of Pheniramine Maleate and Naphazoline Hydrochloride Ophthalmic Solution were ordained as UV spectroscopy and HPLC, respectively. Simultaneous analysis of those using HPLC has been developed. The assays of two drug products were 97.2%, 102.2% (pheniramine maleate), 96.8%, 101.3% (naphazoline HC1) respectively ; the specification rage if 90.0∼110.0%. (omitted)

• Journal of Pharmaceutical Investigation
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• v.40 no.1
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• pp.63-66
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• 2010

The "Guidance Document for Bioequivalence Study" was revised for adding to bioequivalence studies of controlled-release products after meal(Korea Food & Drug Administration Notification #2008-22, 2008.5.7). The bioequivalence study design for controlled-release products is $2{\times}2$ crossover under fast and fed condition in respect. For studies of controlled-release products under fed study, the same high-fat diet should be taken within 20 minutes in at least a 10-hour fasting state. The drug products should be administered 30 minutes after the meal started. A high-fat(more than 35 percent of total caloric content of the meal) and high-calorie(over 900 calories) meal is recommended as a test meal for fed BE studies.

• YAKHAK HOEJI
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• v.56 no.4
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• pp.211-216
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• 2012

Drug dissolution test has been used for the purpose of both quality control of solid oral dosage forms and predicting in vivo drug release profiles. In this study, the dissolution profiles of buflomedil hydrochloride tablets and ticlopidine hydrochloride tablets were investigated according to the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korean Pharmacopoeia (KP). The analytical method using HPLC was validated. The validation was performed in terms of specificity, linearity, accuracy, precision and limit of quantitation.

• Analytical Science and Technology
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• v.25 no.1
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• pp.76-82
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• 2012

The determination and confirmation of dutasteride in human serum was performed by a liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI/MS/MS). Beclomethasone as an internal standard (I.S.) was added to the serum and the mixed sample was pretreated by liquid-liquid extraction (LLE) with methyl tert-butyl ether (MTBE). The mass transitions of dutasteride and I.S. monitored in multiple reaction monitoring (MRM) were m/z 529.6${\rightarrow}$461.5 and m/z 409.3${\rightarrow}$391.2, respectively, and the retention times were 6.45 and 5.46 min, respectively. The calibration curve was linear in the concentration range of 0.5~30.0 ng/mL ($R^2$= 0.9999) and the limit of quantitation (LOQ) was found to be 0.5 ng/mL. The recovery of dutasteride was shown to be 66~72%. The intra-day assay precision and accuracy were in the range 3.5~5.5% and 85.7~89.9%, respectively, and the interday assay precision and accuracy were in the range 4.2~5.8% and 90.8~95.8%, respectively.

• Korean Journal of Environmental Agriculture
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• v.38 no.4
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• pp.321-331
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• 2019

BACKGROUND: Pinoxaden is the phenylpyrazoline herbicide developed by Syngenta Crop Protection, Inc. and marketed on 2006. The maximum residue levels for wheat and barley were set by import tolerance. Thus, Ministry of Food and Drug Safety (MFDS) official analytical method determining Pinoxaden residue was necessary in various food matrixes. Satisfaction of international guideline of CODEX (Codex Alimentarius Commission CAC/GL 40) and National Institute of Food and Drug Safety Evaluation-MFDS (2017) are additional pre-requirements for analytical method. In this study, liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was investigated to analyze residue of Pinoxaden (M4), which is defined as pesticide residue in Korea, in foods. METHODS AND RESULTS: Pinoxaden (M4) was extracted followed by acid digestion (2hr reflux with 1N HCl) and pH adjusting (pH 4-5 with 3% ammonium solution). To remove oil, additional clean-up step with hexane saturated with acetonitrile was required to high oil contained sample before purification. HLB cartridge and nylon syringe filter were used for purification. Then, samples were analyzed by LC-MS/MS using reserve phase column C₁₈. Five agricultural group representative commodities (mandarin, potato, soybean, hulled rice, and red pepper) were used to verify the method in this study. The liner matrix-matched calibration curves were confirmed with coefficient of determination (r²) > 0.99 at calibration range 0.002-0.2 mg/kg. The limits of detection and quantitation were 0.004 and 0.01 mg/kg, respectively, which were suitable to apply Positive List System (PLS). Mean average accuracies of pinoxaden (M4) were shown to be 74.0-105.7%. The precision of pinoxaden and its metabolites were also shown less than 14.5% for all five samples. CONCLUSION: The method investigated in this study was suitable to CODEX (CAC/GL 40) and National Institute of Food and Drug Safety Evaluation-MFDS (2017) guideline for residue analysis. Thus, this method can be useful for determining the residue in various food matrixes in routine analysis.

• Journal of Food Hygiene and Safety
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• v.30 no.3
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• pp.289-294
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• 2015

The aim of this study was to develop rapid screening method for the identification of Chinese herbal medicine species with similar appearance, Polygonum multiflorum, Cynanchum wilfordii and C. auriculatum, by using genetic markers. As a genetic marker, psbA-trnH gene in chloroplast was selected due to differences in sequence among the three species. Species-specific primers were designed based on the sequences of the marker gene of P. multiflorum, C. wilfordii, and C. auriculatum, and the expected size of PCR products was 160, 147, and 119 bp, respectively. Under the developed conditions, cross-reaction was not detected among these three plant species. To confirm the efficiency of our species-specific primers, the optimized method was applied to a variety of processed products composed of mostly P. multiflorum and C. wilfordii, demonstrating that our method was a rapid and easy screening assay. Our findings suggest this screening method can be utilized to prevent the distribution of economically motivated adulteration food and to improve consumer's right.

• Journal of Food Hygiene and Safety
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• v.25 no.4
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• pp.388-394
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• 2010

Metabolomics aims at the comprehensive, qualitative and quantitative analysis of wide arrays of endogenous metabolites in biological samples. It has shown particular promise in the area of toxicology and drug development, functional genomics, system biology and clinical diagnosis. In this study, analytical technique of MS instrument with high resolution mass measurement, such as time-of-flight (TOF) was validated for the purpose of investigation of amino acids, sugars and fatty acids. Rat urine and serum samples were extracted by selected each solvent (50% acetonitrile, 100% acetonitrile, acetone, methanol, water, ether) extraction method. We determined the optimized liquid chromatography/time-of-flight mass spectrometry (LC/TOFMS) system and selected appropriated columns, mobile phases, fragment energy and collision energy, which could search 17 metabolites. The spectral data collected from LC/TOFMS were tested by ANOVA. Obtained with the use of LC/TOFMS technique, our results indicated that (1) MS and MS/MS parameters were optimized and most abundant product ion of each metabolite were selected to be monitorized; (2) with design of experiment analysis, methanol yielded the optimal extraction efficiency. Therefore, the results of this study are expected to be useful in the endogenous metabolite fields according to validated SOP for endogenous amino acids, sugars and fatty acids.

• Proceedings of the PSK Conference
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• 2003.10b
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• pp.192.1-192.1
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• 2003

Acanthopanax cortex (Acanthopanax sessiliflorum, Araliaceae, KP VIII), an important herbal drug, has been used as tonic, antistress and immuno-enhancing drugs in Korea. And Peiplocae cortex(Periploca sepium, Asclepiadaceae, CP 2000) has been used as cardiotonic, anti-inflammatory, and sedative effect in china. These are called “Namogapi” of Acanthopanax cortex and “Bukogapi” of Periplocae cortex in Chinese herbal market. These herbal medicines are sometimes circulated as same herbal medicine “Ogapi”. (omitted)

• Proceedings of the PSK Conference
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• 2002.10a
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• pp.396.1-396.1
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• 2002

HPTLC(High Performance Thin Layer Choromatography) method was developed for rapid and precise analysis of Sildenafil and modified Sildenafils(Vardenafil. Homosildenafil, Tadanafil). Chromatographic conditions were Optimized for simultaneous analysis of them and each specific UV spectra were obtained. The calibration curve of Sildenafil and modified Sildenafils had a linearity in the range of 1.0 ~ 56.5 $\mu$/ml at 254nm. The Limit of Detection(LOD) and the limit of Quantification(LOQ) of Sildenafil and modified Sildenafils were 0.8$\mu$/ml and 1.0$\mu$g/ml. (omitted)