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An HPLC method for the determination of thioctic acid in raw material and tablets
Mai, Xuan-Lan,Ahn, GyeChan,Lee, SeokHan,Kang, Jong-Seong,Woo, Mi Hee,Na, Dong-Hee,Chun, In-Koo,Kim, Kyeong Ho The Korean Society of Analytical Science 2017 분석과학 Vol.30 No.5
Thioctic acid is a vitamin-like antioxidant which is prepared as tablets and injection. The Korean Pharmacopoeia (KP XI) contains monograph for the quality control of raw thioctic acid using ultra-violet visible spectrophotometry and its formulations using high performance liquid chromatography (HPLC). In British Pharmacopoeia 2013 (BP2013), another HPLC method is used for the assay test of thioctic acid material. For the international harmonization, we present an HPLC method for quantitation of thioctic acid in both raw material and tablets. Method validation was performed to determine linearity, precision, accuracy, system suitability, and robustness. The linearity of calibration curves in the desired concentration range was high ($r^2=0.9995$), while the RSDs for intra- and inter-day precision were 0.93 ~ 1.26 % and 1.40 ~ 1.76 %, respectively. Accuracies ranged from 98.13-100.00 %. Since the system suitability, intermediate-precision and robustness of the assay were satisfactory, this method will be a valuable addition to the Korean Pharmacopoeia (KP XI).
Simultaneous determination of ampicillin sodium and sulbactam sodium in powder for injection by HPLC
Mai, Xuan-Lan,Pham, Thuy-Vy,Han, Ga-Hyun,Kum, Su-Jin,Woo, Sang-Hoon,Kang, Jong-Seong,Woo, Mi Hee,Na, Dong-Hee,Chun, In-Koo,Kim, Kyeong Ho The Korean Society of Analytical Science 2019 분석과학 Vol.32 No.4
Ampicillin and Sulbactam (2:1, w/w) are combined in formulation to provide broader antibacterial action in treatment of many infections. The development of analytical method for simultaneouly determine these two compounds was difficult because of the differences in their chemical structures and ratio in the formulation. Current published methods still have some limitations. In this study, we developed an alternative high-performance liquid chromatography (HPLC) assay method for simultaneously determination of ampicillin sodium and sulbactam sodium in powder for injection. Method validation of HPLC method was conducted to determine linearity, precision, accuracy, system suitability, robustness. The linearity of the calibration curves in the desired concentration range was good ($r^2$> 0.9994). RSDs of intra-day and inter-day precision obtained were less than 2.00 %. Accuracy was obtained with the recoveries in range of 98.42 % and 101.36 %. As a result of system suitability, RSD of both retention time and the peak area obtained were not more than 1.0 %. The values of plate number were more than 7000 and symmetric factors obtained were 0.8. As intermediate-precision and robustness of the developed assay, it could be expected to become valuable tools for revising the Korean Pharmacopoeia (KP XI).
Xuan-Lan Mai,Yusung Choi,Quoc-Ky Truong,Thi-Ngoc-Van Nguyen,Sang Beom Han,Kyeong Ho Kim 한국분석과학회 2020 분석과학 Vol.33 No.4
Separation of basic compounds using reverse phase chromatography on a silica-based stationary phase represents a major challenge, because of the interaction between the cationic sites of the basic compounds with the anionic silanols of the stationary phase. This study presents a simple, reliable, and organic solvent - free liquid chromatographic method for the determination of terbutaline and salbutamol, in which a room temperature ionic liquid (RTIL) is used as mobile phase additive. We investigated various mobile phase parameters affecting the retention of the two compounds, such as types and concentration of RTILs and, pH of the mobile phase were investigated. The developed method was validated according to International Conference on Harmonization (ICH) guidelines and successfully applied effectively to determine salbutamol sulfate in pharmaceutical preparations.
Simultaneous determination of ampicillin sodium and sulbactam sodium in powder for injection by HPLC
Xuan-Lan Mai,Thuy-Vy Pham,Ga-Hyun Han,Su-Jin Kum,Sang-Hoon Woo,Jong-Seong Kang,Mi Hee Woo,Dong-Hee Na,In-Koo Chun,김경호 한국분석과학회 2019 분석과학 Vol.32 No.4
Ampicillin and Sulbactam (2:1, w/w) are combined in formulation to provide broader antibacterial action in treatment of many infections. The development of analytical method for simultaneouly determine these two compounds was difficult because of the differences in their chemical structures and ratio in the formulation. Current published methods still have some limitations. In this study, we developed an alternative highperformance liquid chromatography (HPLC) assay method for simultaneously determination of ampicillin sodium and sulbactam sodium in powder for injection. Method validation of HPLC method was conducted to determine linearity, precision, accuracy, system suitability, robustness. The linearity of the calibration curves in the desired concentration range was good (r2 > 0.9994). RSDs of intra-day and inter-day precision obtained were less than 2.00 %. Accuracy was obtained with the recoveries in range of 98.42 % and 101.36 %. As a result of system suitability, RSD of both retention time and the peak area obtained were not more than 1.0 %. The values of plate number were more than 7000 and symmetric factors obtained were 0.8. As intermediate-precision and robustness of the developed assay, it could be expected to become valuable tools for revising the Korean Pharmacopoeia (KP XI).
장해종,Xuan Lan Mai,이건희,안재영,이종숙,Quoc-Ky Truong,Dinh Vin,홍종기,김경호 사단법인 한국질량분석학회 2018 Mass spectrometry letters Vol.9 No.4
An innovative, simple, and rapid assay method based on liquid chromatography coupled with tandem mass spec- trometry (LC-MS/MS) was developed and validated for the simultaneous determination of eight statin drugs in human urine. A simple sample clean-up procedure using the “dilute and shoot” (DAS) approach enabled a fast and reliable analysis. The influ- ence of the dilution factor was investigated to ensure detectability and reduce the matrix effect. Chromatographic separation was performed on a Phenomenex Kinetex C18 column (50 × 3.0 mm i.d., 2.6 µm) using an elution gradient of mobile phase A com- posed of 0.1% acetic acid, and mobile phase B composed of acetonitrile, at a flow rate of 0.35 mL/min. Quantitation was per- formed on a triple quadrupole mass spectrometer operated in multiple reaction monitoring (MRM) mode using electrospray ionization in positive ion mode. The total chromatographic run time was 15 min. The method was validated for selectivity, sen- sitivity, recovery, linearity, accuracy, precision, and stability. The present method was successfully applied to the analysis of Rosuvastatin in urine samples after oral administration to healthy human subjects.
Jang, Haejong,Mai, Xuan-Lan,Lee, Gunhee,Ahn, Jae Hyoung,Rhee, Jongsook,Truong, Quoc-Ky,Vinh, Dinh,Hong, Jongki,Kim, Kyeong Ho Korean Society for Mass Spectrometry 2018 Mass spectrometry letters Vol.9 No.4
An innovative, simple, and rapid assay method based on liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) was developed and validated for the simultaneous determination of eight statin drugs in human urine. A simple sample clean-up procedure using the "dilute and shoot" (DAS) approach enabled a fast and reliable analysis. The influence of the dilution factor was investigated to ensure detectability and reduce the matrix effect. Chromatographic separation was performed on a Phenomenex Kinetex C18 column ($50{\times}3.0mm$ i.d., $2.6{\mu}m$) using an elution gradient of mobile phase A composed of 0.1% acetic acid, and mobile phase B composed of acetonitrile, at a flow rate of 0.35 mL/min. Quantitation was performed on a triple quadrupole mass spectrometer operated in multiple reaction monitoring (MRM) mode using electrospray ionization in positive ion mode. The total chromatographic run time was 15 min. The method was validated for selectivity, sensitivity, recovery, linearity, accuracy, precision, and stability. The present method was successfully applied to the analysis of Rosuvastatin in urine samples after oral administration to healthy human subjects.
LE Thi Lan Huong,HOANG Vu Hiep,HOANG Mai Duc Minh,NGUYEN Hong Phuc,BUI Xuan Bach 한국유통과학회 2022 유통과학연구 Vol.20 No.6
Purpose: This research aims to provide empirical evidence on the impact of digital literacy on behavioural intention regarding using technology for distribution of higher education. Design, Methodology, and Approach: Quantitative analysis was carried out using Covariance-Based Structural Equation Model with data collected from 901 students who fully experienced 2-year study online at different universities in Vietnam. The structural model was built with digital literacy as the primary indicator and other variables were included based on modified version of Unified Theory of Acceptance and Use of Technology (UTAUT2) by adopting performance expectancy, effort expectancy, social influence, habit, and hedonic motivation variables specifically for education sector. Self-efficacy was added to eliminate possible bias in technology acceptance. Results: From the results of model estimation, digital literacy presented positive impact on the online distribution of higher education in Vietnam. The mediating effects of various indicators such as performance expectancy, effort expectancy, social influence, habit, hedonic motivation, and self-efficacy are significantly determined by research model. Conclusion: The higher level of digital literacy of the students, the more likely that they will use technology in higher education study, especially online learning. Additionally, the mediating effects of indicators from the UTAUT2 theoretical model were also evident to be positively significant.