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.
Key words：Valsartan and hydrochlorothiazide tablets;Dissolution;Linear equations;Mathematical separation model;Fiber-chemical sensor
丁海燕1，李改茹1，于迎阁2，周冬冬2，郭 伟1，支 玲1，李新霞1* . 基于线性方程组数学分离模型建立光纤传感过程检测复方缬沙坦氢氯噻嗪片溶出度 [J]. 光谱学与光谱分析, 2014, 34(04): 1056-1059.
DING Hai-yan1, LI Gai-ru1，YU Ying-ge2, ZHOU Dong-dong2, GUO Wei1, ZHI Ling1, LI Xin-xia1* . Process Monitoring of Dissolution of Valsartan and Hydrochlorothiazide Tablets by Fiber-Chemical Sensor Assisted by Mathematical Separation Model of Linear Equations. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2014, 34(04): 1056-1059.
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