ABSTRACT Objective： To develop a reliable method to assess the stability of Xinyue Capsules （心悦胶囊） containing Panax quinquefolius saponins according to European quality standards. Methods： An efficient high-pe...ABSTRACT Objective： To develop a reliable method to assess the stability of Xinyue Capsules （心悦胶囊） containing Panax quinquefolius saponins according to European quality standards. Methods： An efficient high-performance liquid chromatography ultraviolet （HPLC-UV） method was established to analyse six main ginsenosides （Rb1, Rb2, Rc, Rd, Re and Rg1） in six different batches （120 capsules/batch） from the same lot of Xinyue Capsules and in one batch measured six times within one day. The six ginsenosides were separated on a Hypersil BDS-C18 column （3 μm, 100 mm × 3 mm） at a flow rate of 0.5 mL/min. Gradient elution was performed using a mobile phase gradient of acetonitrile-water modified with 0.01% formic acid. The HPLC chromatograms were analyzed with ＂LC data comparison＂ using Lab Solutions software. Results： The HPLC peaks were identified by comparing their retention times （Rg1： 23.44 min, Re： 23.77 rain, Rb1： 35.24 min, Rc： 36.18 min, Rb2：38.55 min and Rd： 40.88 min） with those of the standards under the same chromatographic conditions, which showed similar results among the samples of six different batches and among the samples from one batch detected six times within one day. Conclusions： Xinyue Capsules have good drug intra-day consistency at room temperature and exhibit a consistent quality between different batches. This study established a reliable method to assess the stability of Xinyue Capsules, which is suitable for further qualitative analysis and may assist in promoting the safe and effective use of Chinese herbal medicine.展开更多
In this paper, a high-performance liquid chromatography coupled with ultraviolet detection and Fourier transform-ion cyclotron resonance mass spectrometry （HPLC-UV/FrICRMS） method was described for the investigation...In this paper, a high-performance liquid chromatography coupled with ultraviolet detection and Fourier transform-ion cyclotron resonance mass spectrometry （HPLC-UV/FrICRMS） method was described for the investigation of impurity profile in moxifloxacin （MOX） drug substance and chemical reference substance. Ten impurities were detected by HPLC-UV, while eight impurities were identified by using the high accurate molecular mass combined with multiple-stage mass spectrometric data and fragmentation rules. In addition, to our knowledge, five impurities were founded for the first time in MOX drug substance.展开更多
基金Supported by the National Natural Scientific Fund of China(No.81273933,81102722)the International Science and Technology Cooperative Project from the Ministry of Science and Technology of China(No.2010DFA31690)the Austrian Federal Ministry of Science and Research and the Austrian Federal Ministry of Health(No.GZBMWF-402.000/3-Ⅳ6b/2008)
文摘ABSTRACT Objective： To develop a reliable method to assess the stability of Xinyue Capsules （心悦胶囊） containing Panax quinquefolius saponins according to European quality standards. Methods： An efficient high-performance liquid chromatography ultraviolet （HPLC-UV） method was established to analyse six main ginsenosides （Rb1, Rb2, Rc, Rd, Re and Rg1） in six different batches （120 capsules/batch） from the same lot of Xinyue Capsules and in one batch measured six times within one day. The six ginsenosides were separated on a Hypersil BDS-C18 column （3 μm, 100 mm × 3 mm） at a flow rate of 0.5 mL/min. Gradient elution was performed using a mobile phase gradient of acetonitrile-water modified with 0.01% formic acid. The HPLC chromatograms were analyzed with ＂LC data comparison＂ using Lab Solutions software. Results： The HPLC peaks were identified by comparing their retention times （Rg1： 23.44 min, Re： 23.77 rain, Rb1： 35.24 min, Rc： 36.18 min, Rb2：38.55 min and Rd： 40.88 min） with those of the standards under the same chromatographic conditions, which showed similar results among the samples of six different batches and among the samples from one batch detected six times within one day. Conclusions： Xinyue Capsules have good drug intra-day consistency at room temperature and exhibit a consistent quality between different batches. This study established a reliable method to assess the stability of Xinyue Capsules, which is suitable for further qualitative analysis and may assist in promoting the safe and effective use of Chinese herbal medicine.
基金the Ministry of Public Health of the People's Republic of China(No200802038) for financial support
文摘In this paper, a high-performance liquid chromatography coupled with ultraviolet detection and Fourier transform-ion cyclotron resonance mass spectrometry （HPLC-UV/FrICRMS） method was described for the investigation of impurity profile in moxifloxacin （MOX） drug substance and chemical reference substance. Ten impurities were detected by HPLC-UV, while eight impurities were identified by using the high accurate molecular mass combined with multiple-stage mass spectrometric data and fragmentation rules. In addition, to our knowledge, five impurities were founded for the first time in MOX drug substance.
