光谱学与光谱分析 |
|
|
|
|
|
Process Monitoring of Dissolution of Valsartan and Hydrochlorothiazide Tablets by Fiber-Chemical Sensor Assisted by Mathematical Separation Model of Linear Equations |
DING Hai-yan1, LI Gai-ru1,YU Ying-ge2, ZHOU Dong-dong2, GUO Wei1, ZHI Ling1, LI Xin-xia1* |
1. College of Pharmacy, Xinjiang Medical University, Urumqi 830011, China 2. College of Traditional Chinese Medicine, Xinjiang Medical University, Urumqi 830011, China |
|
|
Abstract A method for on-line monitoring the dissolution of Valsartan and hydrochlorothiazide tablets assisted by mathematical separation model of linear equations was established. UV spectrums of valsartan and hydrochlorothiazide were overlapping completely at the maximum absorption wavelength respectively. According to the Beer-Lambert principle of absorbance additivity, the absorptivity of Valsartan and hydrochlorothiazide was determined at the maximum absorption wavelength, and the dissolubility of Valsartan and hydrochlorothiazide tablets was detected by fiber-optic dissolution test (FODT) assisted by the mathematical separation model of linear equations and compared with the HPLC method. Results show that two ingredients were real-time determined simultaneously in given medium. There was no significant difference for FODT compared with HPLC (p>0.05). Due to the dissolution behavior consistency, the preparation process of different batches was stable and with good uniformity. The dissolution curves of valsartan were faster and higher than hydrochlorothiazide. The dissolutions at 30 min of Valsartan and hydrochlorothiazide were concordant with US Pharmacopoeia. It was concluded that fiber-optic dissolution test system assisted by the mathematical separation model of linear equations that can detect the dissolubility of Valsartan and hydrochlorothiazide simultaneously, and get dissolution profiles and overall data, which can directly reflect the dissolution speed at each time. It can provide the basis for establishing standards of the drug. Compared to HPLC method with one-point data, there are obvious advantages to evaluate and analyze quality of sampling drug by FODT.
|
Received: 2013-07-03
Accepted: 2013-10-20
|
|
Corresponding Authors:
LI Xin-xia
E-mail: lxx6668@163.com
|
|
[1] USP36, 2013. 5540. [2] State Food and Drug Administration Standards (Trial)(国家食品药品监督管理局标准(试行)): YBH05152005. [3] State Pharmacopoeia Commission of the People’s Republic of China(中华人民共和国国家药典委员会). Valsartan and hydrochlorothiazide Tablets National Standards Draft(缬沙坦氢氯噻嗪片国家标准草案), 2012. 1. [4] YAO Jun,SHEN Jing,WANG Yan, et al(姚 军,沈 静,王 岩,等). Chinese Journal of Spectroscopy Laboratory(光谱实验室), 2010,27(6):2135. [5] Nie K, Li L, Li X, et al. Dissolution Technol., 2009, 16(1): 14. [6] Nie K, Li L, Li X, et al. Dissolution Technol., 2010, 17(2): 15. [7] China Food and Drug Administration(国家食品药品监督管理局). Guiding Principles of Drug Evaluation Sampling Quality Analysis(药品评价抽验质量分析指导原则), 2009. 30. [8] SUN Yu-qing(孙毓庆). Analytical Chemistry(分析化学). Beijing: People’s Health Publishing House(北京:人民卫生出版社),1997. 30. |
[1] |
FENG Wei-yi1, 2, LIU Li-hua1*, ZHANG Xu-ping2, ZHAO Xia1, HUANG Xiao-wei1, YU Chun-han3. Study on Leakage Detection Technology of Corrosive Acid Solution Based on Fiber Raman Temperature Measurement[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2020, 40(11): 3425-3429. |
[2] |
YUAN Ting-ting, HUANG Peng, LI Han-yang, SHANG Yan-ting, YANG Xing-hua, ZHANG Yang, LI Han-yang, ZHAO En-ming*. Design and Research for a Kind of Optical Fiber Sensor Based on Extroradinary Optical Tramsimission Phenomenon[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2018, 38(03): 681-684. |
[3] |
ZHANG Yan-jun, GAO Hao-lei, FU Xing-hu*, TIAN Yong-sheng, WANG Hui-min, ZHANG Yi-nan. Threshold of Brillouin Scattering in a Few-Mode Fiber[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2018, 38(01): 285-289. |
[4] |
CHEN Chen, LI Xian-li, DING Hui*. A Novel Wavelength Demodulation Technique for Interferometric Fiber Optic Sensor[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2017, 37(09): 2948-2953. |
[5] |
SUN Ming-ming, WANG Jian-feng, JIN Yong-xing*, DONG Xin-yong. All-Fiber Mach-Zehnder Interferometer Based on Lateral-Offset and Peanut Shape Structure[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2016, 36(05): 1560-1564. |
[6] |
ZHANG Fu-cai1, SUN Xiao-gang1*, XING Jian2. Study on the Multi-Spectral True Temperature Pyrometer for Explosion Transient of Thermo-Baric Explosives[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2016, 36(05): 1598-1603. |
[7] |
ZHANG Yan-jun1, 2, LIU Wen-zhe1, FU Xing-hu1, 2*, BI Wei-hong1, 2 . An Extraction and Recognition Method of the Distributed Optical Fiber Vibration Signal Based on EMD-AWPP and HOSA-SVM Algorithm [J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2016, 36(02): 577-582. |
[8] |
ZHANG Yan-jun1, 2, LIU Wen-zhe1, FU Xing-hu1, 2*, BI Wei-hong1, 2 . A Brillouin Scattering Spectrum Feature Extraction Based on Flies Optimization Algorithm with Adaptive Mutation and Generalized Regression Neural Network[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2015, 35(10): 2916-2923. |
[9] |
ZHANG Yan-jun1, 2, LIU Wen-zhe1, FU Xing-hu1, 2*, BI Wei-hong1, 2 . The High Precision Analysis Research of Multichannel BOTDR Scattering Spectral Information Based on the TTDF and CNS Algorithm [J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2015, 35(07): 1802-1807. |
[10] |
FENG Xin-jie1, MAO Pei-ling1, CHEN Xiao-long1, LUO Yun-han1, 2*, PENG Shui-hua1, CHEN Chao-ying1, WANG Fang1, TANG Jie-yuan1, 2, YU Jian-hui1, 2, ZHANG Jun1, 2, LU Hui-hui1, 2, CHEN Zhe1, 2 . Design and Optimization of Surface Plasmon Resonance Sensor Based on Side Polished Single-Mode Fiber [J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2015, 35(05): 1419-1423. |
[11] |
YAO Jun1, SHEN Jing2*, LI Li1*, LI Xin-xia1, CHEN Jian1 . Development and Application of Six-Channel Fiber Optic Sensing Drug Dissolution Monitor[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2014, 34(09): 2587-2590. |
[12] |
ZHAO Na1, FU Hai-wei1, 2*, SHAO Min1, 2, LI Hui-dong1, LIU Ying-gang1, QIAO Xue-guang2 . Research on High Sensitivity Temperature Sensor Based on Mach-Zehnder Interferometer with Waist-Enlarged Fiber Bitapers [J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2014, 34(06): 1722-1726. |
[13] |
YUAN Cheng-xu, WANG Zi-nan*, JIA Xin-hong, LI Jin, YAN Xiao-dong, CUI An-bin . 94 km Brillouin Distributed Optical Fiber Sensors Based on Ultra-Long Fiber Ring Laser Pumping [J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2014, 34(05): 1191-1195. |
[14] |
LUO Yun-han1, CHEN Xiao-long1, XU Meng-yun1, GE Jia1, ZHANG Yi-long2, HE Yong-hong2, TANG Jie-yuan1, YU Jian-hui1, ZHANG Jun1, CHEN Zhe1, CHEN Xing-dan1 . Spectra Modulated Surface Plasmon Resonance Sensor Based on Side Polished Multi-Mode Optical Fiber[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2014, 34(03): 577-581. |
[15] |
WANG Tao, HE Da-wei*, WANG Yong-sheng, QUAN Yu, WANG Peng-fei, YIN Ze-lin . Spectral Repeatability of Regenerated Fiber Gratings Prepared by High Temperature Annealing[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2013, 33(05): 1411-1414. |
|
|
|
|