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Truong, Quoc-Ky,Mai, Xuan-Lan,Kim, Dae Hyun,Kim, Jeon Kyung,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.1
In attempt to contribute in official monographs of Korean Pharmacopoeia, an HPLC method was developed and fully validated for the determination of tolperisone hydrochloride in tablets which have never been published in other forgein Pharmacopoeia. Analysis was carried out in an ODS column ($250{\times}4.6mm$ I.D., $5{\mu}m$) with common solvents include acetonitrile and ammonium hydrophosphate buffer as mobile phase. The assay was validated according to International Conference on Harmonization (ICH) guidelines. The method has good linearity in the range of $5-200{\mu}g/mL$ tolperisone. Intra-day precision varied between 0.04 and 0.10 %. Relative standard deviations of inter-day precision ranged between 0.43 and 1.24 % for peak area. The percentage recovery of the tolperisone ranged between 99.8 and 101.2 % in material. Recoveries in tablets were ranged between 98.7 and 100.8 %, thus confirmed the suitability of method for estimation of tolperisone hydrochloride in tablet dosage form.
Quoc Ky Truong,Xuan Lan Mai,이재용,이종숙,Dinh Vinh,홍종기,김경호 대한약학회 2018 Archives of Pharmacal Research Vol.41 No.5
A simple, sensitive, and rapid assay based onhydrophilic interaction liquid chromatography (HILIC)with tandem mass spectrometry was developed and validatedfor the simultaneous determination of metformin and13 other oral antihyperglycaemic drugs in human urineusing metoprolol as an internal standard. A simple sampleclean-up procedure using the ‘‘dilute and shoot’’ approachenabled fast and reliable analysis. Chromatographic separationwas performed on a HILIC column using an elutiongradient of mobile phase A, composed of 1 mM ammoniumformate (pH 5), and mobile phase B, composed ofacetonitrile, at a flow rate of 0.35 mL/min. Quantitationwas performed on a triple quadrupole mass spectrometeroperated in multiple reaction monitoring mode by usingelectrospray ionization in positive ion mode. The totalchromatographic run time was 20 min. Calibration curvesfor each analyte were linear over concentration ranges of2–300, 5–400, or 20–500 ng/mL, with a coefficient ofdetermination above 0.99. The method was validated forselectivity, sensitivity, recovery, linearity, accuracy andprecision, system suitability, robustness, and stability. Inter-batch and intra-batch coefficients of variation acrossfour validation runs were B 13.62%. The present methodwas successfully applied for the analysis of metformin andnateglinide in urine samples after their oral administrationto healthy human subjects under fasted conditions.
Determination of S-(2)-lansoprazole in dexlansoprazole preparation by capillary zone electrophoresis
정현규,Quoc Ky Truong,Xuan-Lan Mai,최유성,강종성,Woongchon Mar,김경호 대한약학회 2017 Archives of Pharmacal Research Vol.40 No.8
Capillary zone electrophoresis was successfullyapplied to the enantiomeric purity determination ofdexlansoprazole using sulfobutyl ether-b-cyclodextrin andmethyl-b-cyclodextrin as chiral selectors. Separations werecarried out in a 50 lm, 64/56 cm fused-silica capillary. The optimized conditions included 90 mM phosphatebuffer, pH 6.0, containing 30 mM sulfobutyl ether-b-cyclodextrin,20 mM methyl-b-cyclodextrin as backgroundelectrolyte, an applied voltage of 25 kV and a temperatureof 16 C, detection was at 280 nm. The assay wasvalidated for the S-(-)-lansoprazole in the range of0.2–1.0%. The limit of detection was 0.07%, the limit ofquantitation was 0.20%, relative to a total concentration of4.0 mg mL-1. Intra-day precision varied between 1.72 and2.07%. Relative standard deviations of inter-day precisionranged between 1.62 and 1.96% for peak area ratio. Theassay was applied for the determination of the chiral purityof dexlansoprazole capsules. Recovery in capsules wasranged between 101.7 and 103.1%.
김미리,유수경,Quoc Ky Truong,Xuan Lan Mai,정현규,강종성,김경호 대한약학회 2017 Archives of Pharmacal Research Vol.40 No.3
Rabeprazole is one of the latest proton-pumpinhibitors used for treatment of several gastrointestinaldisorders. For therapeutic applications, rabeprazole hasbeen administered as a mixture of R-(?) and S-(-) enantiomers. Owing to pharmacological and toxicological differencesbetween stereoisomers, chiral recognition has nowbecome an integral part of drug research and development. A simple and rapid liquid chromatographic method forenantioselective separation and determination of R-(?) andS-(-) enantiomers of rabeprazole in bulk drug and pharmaceuticalformulations was developed. Chiralpak IC(150 9 4.6 mm, 5 lm) column and lmobile phase containinghexane:ethanol:ethylenediamine (30:70:0.05 v/v) inan isocratic mode yielded baseline separation with resolutiongreater than 6.0 at 35 C. Effects of additives andn-hexane were evaluated. Optimized condition was validatedas per ICH guidelines. The method has good linearity,high sensitivity with LOD was 0.01 lg/mL andLOQ was 0.03 lg/mL for both enantiomers. Intra-dayprecision varied between 0.44 and 1.79% for S-(-) enantiomer,0.65 and 1.97% for R-(?) enantiomer. Relativestandard deviations of inter-day precision were less than1.81% for both enantiomers. The percentage recovery forboth enantiomers of rabeprazole ranged between 99.81 and101.95%, 98.82 and 101.36% in material and tablets,respectively. The method was successfully applied todetermine content of each enantiomer in commercialtablets.
Development of HPLC assay method of fusidate sodium tablets
Lee, GaJin,Choi, Min,Truong, Quoc-Ky,Mai, Xuan-Lan,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.3
The Korean Pharmacopoeia (KP XI), British Pharmacopoeia (BP 2013) and Japanese Pharmacopoeia contain monographs for the quality control of raw fusidate sodium and its formulations using high performance liquid chromatography (HPLC). However, the assay method for the determination of fusidate sodium in commercial tablets is titration which is less specific than HPLC. In this study, we present an alternative HPLC method for quantitation of fusidate sodium in 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 ($r^2=0.9999$), while the RSDs for intra- and inter-day precision were 0.25-0.37 % and 0.11-0.60 %, respectively. Accuracies ranged from 99.46-100.85 %. 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).
Determination of urazamide in pharmaceutical preparation with room temperature ionic liquid
서나래,이유림,박현선,Quoc Ky Truong,이재용,정현규,최유성,김병희,한상범,김경호 대한약학회 2017 Archives of Pharmacal Research Vol.40 No.3
A high performance liquid chromatographic the proper retention time. The assay was validatedaccording to International Conference on Harmonizationguidelines. The linearity of the calibration curve was good(r2[0.999). Intra-day precision varied between 0.50 and1.23%. Relative standard deviations of inter-day precisionranged between 1.07 and 1.66%. Recoveries in tabletsranged between 99.7 and 101.2% and it was successfullyapplied to determine urazamide in pharmaceuticalpreparations. method was developed and validated for the determinationof urazamide in pharmaceutical preparation with novelgreen aqueous mobile phase modified with room temperatureionic liquids (RTILs). 1-Ethyl-3-methyl-imidazoliumtetrafluoroborate ([EMIM][BF4]) was selected as a mobilephase additive to improve retention and avoid baselinedisturbances at t0. Various mobile phase parameters such ascation moiety, chaotropic anion moiety, pH and concentrationof RTILs were optimized to determine urazamide at
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.