1.HPLC-RID method for the determination of glucosamine hydrochloride in amitriptyline enteric-coated tablets
YUAN Jinye ; CHEN Qi ; XUE Qiaoru ; CHEN Hua
Drug Standards of China 2024;25(1):062-067
Objective: To establish a method for the determination of glucosamine hydrochloride content in aminoglycine enteric coated tablets by high-performance liquid chromatography with differential refractive detector.
Methods: Waters XBridge Amide (4.6 mm×250 mm, 3.5 μm) column was used. The mobile phase was 80% acetonitrile solution (1 000 mL containing 1 mL ammonia) at the flow rate of 1.2 mL·min-1. Column temperature was set on 40 ℃; Injecting volume was 20 μL with differential refraction detector (RID) detection.
Results: The detection limit of glucosamine hydrochloride was 0.03 mg·mL-1, and the limit of quantification was 0.125 mg·mL-1. It showed a good linear relationship in the mass concentration range of 0.72-7.56 mg·mL-1. The average recovery was 99.4% (RSD=0.85%,n=9). The content of glucosamine hydrochloride in 7 batches of aminosamine enteric-coated tablets was measured in the range of 93%-107%.
Conclusion: The proposed method is fast, accurate, specific and durable, and can be used for the determination of glucosamine hydrochloride, which provides a reference for effectively controlling the quality of aminoxymetacin enteric-coated tablets.
2.Analysis on job stress assessment in BSL-3 laboratories
Yuena DING ; Bifei YUAN ; Jinye LIU ; Zhigang SONG ; Zhong LIN ; Jingqing WENG ; Hangping YAO ; Zhijiao TANG ; Zhiping SUN ; Wendong HAN ; Di TIAN ; Zhitong ZHOU ; Junming DAI ; Di QU
Chinese Journal of Comparative Medicine 2014;(10):82-89
Objective The staffs of biosafety level 3 laboratories (BSL-3) face with the stress of handling highly pathogenic microbs and special laboratory environment.The job stress may result in accidents in the laboratory as negative factor for the risk control.The research may provide support for the control of risk in biosafety laboratories.Methods In order to assess the job stress in the staff in BSL-3 laboratory, we modified “the Chinese simple job stress questionnaire”based on the theory of the JDC mode and ERI mode, and an investigation was carried out.The present study included the staffs (87 employees) from six BSL-3 laboratories located in five provinces ( Shanghai, Zhejiang, Jiangsu, Fujian and Wuhan) .Results Analysis of the data indicates that variables of age, working years, job duties, manipulating of animals, type of microorganisms and transmission route have a significant influence on the level of job stress in BSL-3 laboratory.Conclusion The BSL-3 laboratory staff in higher stress level have the characteristicses:20-39 years old, short work years, regular staff, operating on air-borne microbiology, manipulating of animals and operating on one more microbiology.
3.Content Determination of Related Substances in Terlipressin for Injection by UPLC
Qiaoru XUE ; Jinye YUAN ; Liuyang DING ; Weijun ZHENG ; Feng DENG
China Pharmacy 2020;31(9):1108-1112
OBJECTIVE:To establish UPLC method for the content determination of related substances in Terlipressin for injection. METHODS :UPLC method was used to determine the contents of related substances in 5 batches of Terlipressin for injection. The separation was performed on Xtimate UPLC C 18 column with mobile phase A consisted of ammonium sulfate buffer (pH 2.3)-methanol(90 ∶ 10,V/V)and mobile phase B consisted of ammonium sulfate buffer (pH 2.3)-methanol(60 ∶ 40,V/V) (gradient elution )at the flow rate of 0.2 mL/min. The detection wavelength was set at 210 nm,and sample size was 5 μL. RESULTS:The linear range of impurity A ,B,C,D,F,H,I,K,L and N were 0.43-3.86,0.44-3.95,0.44-3.97,0.45-4.08, 0.45-4.05,0.50-4.50,0.47-4.26,0.47-4.23,0.46-4.13,0.44-3.96 μg/mL(r≥0.999 7),respectively. The detection limits were 0.04, 0.04,0.05,0.04,0.05,0.05,0.05,0.05,0.04 μg/mL. The quantitation limits were 0.13,0.13,0.14,0.13,0.15,0.14,0.14, 0.14,0.13 μg/mL,respectively. RSDs of precision ,reproducibility and stability tests were all lower than 8%. The average recoveries were 94.95%,97.81%,101.88%,95.26%,93.40%,102.48%,104.26%,102.31%,96.42%,90.42%,with RSD s of 1.89%,1.86%,0.68%,1.30%,1.98%,3.36%,1.26%,1.30%,1.19%,1.40%(n=9),respectively. Total contents of impurities in 5 batches of Terlipressin for injection were all lower than 4%. CONCLUSIONS :Established method is rapid ,simple, accurate and specific ,which can be used for the quantitative analysis for related substances in Terlipressin for injection.