|
|
|
|
|
|
A New Method for Determination of Polysorbate 80 in Shengmai Injection Based on Absorption Coefficient |
NIE Li-xing, CHANG Yan, DAI Zhong, MA Shuang-cheng* |
National Institutes for Food and Drug Control, Beijing 100050, China |
|
|
Abstract Polysorbate 80, also known as Tween 80, is an amphipathic non-ionic surfactant commonly used as excipient in the food, personal care and pharmaceutical industries. Particularly, it has been widely used in Traditional Chinese Medicine (TCM) injections to enhance solubility and clarity. In recent years, more attentions have benn paid to the quality and application of polysorbate 80 due to incidence of adverse reactions. Some declared that adding of polysorbate 80 might increase the side effects. To avoid abuse of this excipient, it is essential to control the levels of polysorbate 80 in therapeutic formulations within a target level. Assay of polysorbate 80 in TCM injections has become a hot and difficult issue nowadays. Content of polysorbate 80 in preparations could be quantified directly by spectrophotometry, size-exclusion chromatography coupled with evaporative light scattering detector (SEC-ELSD) or liquid chromatography combined with mass spectrometry (LC-MS) method. Acid hydrolysis followed by high performance liquid chromatography coupled with ultraviolet detector (HPLC-UV) or gas chromatography (GC) determination was also used as an indirect measurement of polysorbate 80. But it's hard to find a unified conversion formula or reference standard for accurate quantification owing to the fact that the surfactant is a complex mixtures of oligomers, whose composition and ratio of chemical components vary by different manufacturers. In addition, it becomes a challenge to measure polysorbate 80 in TCM injections without false-positive interference due to the complex matrix of the preparation. Taking Shengmai Injection as example, a novel method for determination of polysorbate 80 in TCM injections was proposed based on absorption coefficient, which offered a solution for the above problems. After optimization of detection wavelength, chromogenic reagent and of the shaking and standing time of the liquid-liquid extraction, absorption coefficient (E1%1 cm) of cobalt thiocyanate complex of polysorbate 80 was obtained from 6 different bands of instruments as 104.23 with RSD of 2.08%. Shengmai Injection was first diluted by 10 times. To 1.0 mL of the test solution, 10 and 20 mL of dichloromethane were added accurately to form a polysorbate/thiocyanate complex, followed by cyclotron oscillation for 3 minutes. The mixture was transferred into a separating funnel and was stranded for 30 minutes. The first 1 mL of the lower layer was discarded and the next 15 mL was collected. Then the absorbance was measured at 320 nm. Finally the content of polysorbate 80 was calculated by using the previously obtained absorption coefficient based on Lambert-Beer law. With no interference from the negative sample, the established method provided precision and reproducibility (% relative standard deviation) less than 3% and accuracy (% spike recovery) of 98.42%. To further validate the accuracy of the method, 10 batches of Shengmai Injection from 2 manufacturers were determined by both the absorption coefficient method and the standard curve method, and the results were compared with the actual feeding content of polysorbate 80 in the sample. Results of paired t test indicated that there were no significance difference between the results obtained by two methods, or between the results of the absorption coefficient method and the actual feeding content of polysorbate 80 (p>0.05). The investigation selected 320 nm as the detection wavelength to improve the sensitivity, which was never adopted in previous work. In this way, remarkable decrease of matrix interference was achieved, thus the problem of misfit determination results and the actual feeding content of polysorbate 80 was solved. With no need for reference standard or standard curve, the search offered a feasible tool for test standard of polysorbate 80 in TCM injection. All in all, the proposed method was sensitive, accurate, rapid and simple, which can provide key constants and new ideas for quality control of preparations containing polysorbate 80.
|
Received: 2017-12-25
Accepted: 2018-03-29
|
|
Corresponding Authors:
MA Shuang-cheng
E-mail: masc@nifdc.org.cn
|
|
[1] Singh S R, Zhang J, O’Dell C, et al. AAPS Pharmaceutical Science Technology, 2012, 13(2): 422.
[2] Zdravkovic S A. European Journal of Pharmaceutical Sciences, 2016, 93: 475.
[3] Yusuf M, Khan M, Khan R A, et al. Journal of Microencapsulation, 2016, 33(7): 646.
[4] Serno T, Hrtl E, Besheer A, et al. Pharmaceutical Research, 2013, 30(1): 117.
[5] Tian X H, Lin X N, Wei F, et al. International Journal of Nanomedicine, 2011, 6: 445.
[6] ZHANG Rui,WANG Yu,GAO Zheng-song,et al(张 锐,王 玉,高正松,等). Chinese Pharmaceutical Journal(中国药学杂志),2015,50(10):876.
[7] WU Ren-rong,PENG Wen-yong,TU Jia-sheng(吴仁荣,彭文勇,涂家生). Chinese Journal of Pharmaceutical Biotechnology(药物生物技术),2016,23(1):39.
[8] GUO Zhi-xin,SUN Hui-min,YANG Rui,et al(郭志鑫,孙会敏,杨 锐,等). Journal of Pharmaceutical Practice(药学实践杂志),2012,30(6):459.
[9] LI Zhen-hu,WANG Hua-long,LIU Yan-ting,et al(李振虎,王化龙,刘艳庭,等). Chinese Journal of New Drugs(中国新药杂志),2016,25(23):2664.
[10] Hvattuma E, Yip W L, Grace D, et al. Journal of Pharmaceutical and Biomedical Analysis, 2012, 62(2): 7.
[11] HUANG Yun-zhong,YANG Bin,YE Chi-ming,et al(黄运中,杨 彬,叶驰名,等). Chinese Journal of Biologicals(中国生物制品学杂志),2016,29(2):201.
[12] SHEN Juan,ZHANG Qiao,LI Jia-chun,et al(沈 娟,张 桥,李家春,等). China Journal of Chinese Materia Medica(中国中药杂志),2014,39(15):2915.
[13] WU Chun-li,LI Ai-xing,LI Jie-ming,et al(吴春丽,李爱星,李捷明,等). China Pharmacy(中国药房),2012,23(40):3823. |
[1] |
XU Qiu-yi1, 3, 4, ZHU Wen-yue3, 4, CHEN Jie2, 3, 4, LIU Qiang3, 4 *, ZHENG Jian-jie3, 4, YANG Tao2, 3, 4, YANG Teng-fei2, 3, 4. Calibration Method of Aerosol Absorption Coefficient Based on
Photoacoustic Spectroscopy[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2024, 44(01): 88-94. |
[2] |
GAO Jian-kui1,2, LI Yi-jie3, ZHANG Qin-nan1, LIU Bing-wei1, LIU Jing-bo1, LING Dong-xiong1, LI Run-hua2, WEI Dong-shan1*. Temperature Effects on the Terahertz Spectral Characteristics of PEEK[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2021, 41(11): 3347-3351. |
[3] |
BAI Jun-peng1, 2, LI Bin1*, ZHANG Shu-juan2, CHEN Yi-mei1. Study on Norfloxacin Concentration Detection Based on Terahertz Time Domain Spectroscopy[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2021, 41(09): 2710-2716. |
[4] |
HUANG Han1, CHEN Hong-yan2*, LI Xiao-lu1, LIU Jia-hao1, ZHAO Yong-jia2, CHEN Liang3. Calculation and Study of Methane Absorption Coefficient at Variable Pressure and Temperature Under 3 016.49 cm-1 Wave Number[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2021, 41(08): 2462-2468. |
[5] |
HUANG Yu-ping1, WANG De-zhen1, ZHOU Hai-yan1, YANG Yu-tu1, CHEN Kun-jie2*. Ripeness Assessment of Tomato Fruit by Optical Absorption and Scattering Coefficient Spectra[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2020, 40(11): 3556-3561. |
[6] |
CHEN Jie1, 2, 3, QIAN Xian-mei1, 3, LIU Qiang1, 3*, ZHENG Jian-jie1, 2, 3, ZHU Wen-yue1, 3, LI Xue-bin1, 3. Research on Optical Absorption Characteristics of Atmospheric Aerosols at 1 064 nm Wavelength[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2020, 40(10): 2989-2995. |
[7] |
LI Bin, ZHAO Xu-ting, ZHANG Yong-zhen, CHEN Yi-mei. Progress on Terahertz Spectroscopic Detection and Analysis on Antibiotics[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2019, 39(12): 3659-3666. |
[8] |
JIN Hua-wei1, 2, 3, XIE Pin-hua1, 2, HU Ren-zhi1, 2*, LIU Wen-qing1, 2, LI Zhi-yan1, 2, CHEN Hao1, 2, HUANG Chong-chong1, 2. Study on Photo-Acoustic Spectrum Detection Technology of Respiratory Dust Absorption Coefficient[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2019, 39(07): 1993-1998. |
[9] |
LONG Sha1, ZHANG Hua2, SONG Zhe-yu2, 3, YAN Shi-han2*, CUI Hong-liang2, 4. Spectroscopic Studies on the Natural Leather and Artificial Leather in Terahertz Band[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2019, 39(04): 1030-1035. |
[10] |
ZHAO Xu-ting1, 2, 3, ZHANG Shu-juan1, LI Bin2, 3, 4*, LI Yin-kun5. Study on Moisture Content of Soybean Canopy Leaves under Drought Stress Using Terahertz Technology[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2018, 38(08): 2350-2354. |
[11] |
CHEN Xi-ai1,2,3, WU Xue1, ZHANG Song1, WANG Ling1. Study of Plant Growth Regulators Detection Technology Based on Terahertz Spectroscopy[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2018, 38(03): 665-669. |
[12] |
WU Zhi-kui, BAO Ri-ma*, WANG Fang, MIAO Xin-yang, FENG Cheng-jing. Application of Terahertz Time-Domain Spectroscopy in Fluid Inclusion Study[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2017, 37(12): 3689-3692. |
[13] |
LI Jia-yu1, SUN Ping1*, ZOU Yun1, LIU Wei2, WANG Wen-ai2 . Comparison and Analysis of Iterative and Genetic Algorithms Used to Extract the Optical Parameters of Glucose Polycrystalline[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2016, 36(12): 3875-3880. |
[14] |
YAO Xin1,2, SUN Jiang-ling3, DONG Jie1, LIU Xue-li1, LIU Yu-ping1, FANG Xiao-xiao1 . Absorption Characteristics and Environmental Significance of Dissolved Organic Matter in Lake Dongping [J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2016, 36(10): 3232-3236. |
[15] |
ZHOU Sheng-ling1, ZHU Shi-ping1*, LI Guang-lin1, HUANG Jie1, YANG Ya-ling2 . Study on the Measurement and Optimization of Soybean Oil Optical Spectrum in THz Range[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2016, 36(04): 924-928. |
|
|
|
|