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Abstract: [Abstract]〓Objective〖HTSS〗〓To study the stability of refrigerated drug Nicorandil compatible with solvents of different carriers. 〖HTH〗〖WTHZ〗Methods〖HTSS〗〓The solutions of nicorandil dissolved with 0.9% sodium chloride injection or 5% glucose Injection were stored at room temperature or low temperature for 8 h. The concentration of nicorandil was determined by ultrahigh performance liquid chromatography, and the chromatographic conditions were as follows: chromatographic column was ACEC18(50 mm×2.1 mm, 2.5 μm) column and the column temperature was 40 ℃, the mobile phase was methanolwater(42〖DK〗∶58) with a flow rate of 0.4 mL/min, the detection wavelength was set at 254 nm. The changes of pH were measured with pH meter. The number of insoluble particles were surveyed by particle analyzer. 〖HTH〗〖WTHZ〗Results〖HTSS〗〓The linear ranges of nicorandil was 3.316-18.896 mg/L (r=0.999). The concentration of nicorandil and the value of pH were stable after dissolved in different solvents and stored at different temperatures within 8 h. Additionally, the amount of particles(≥25 μm ) was normal, while amount of particles(≥10 μm) was relatively larger. 〖HTH〗〖WTHZ〗Conclusion〖HTSS〗〓When stored at either room temperature or low temperature,the stability of nicorandil solution after dissolved in different solvents is desirable within 8 h, while the amount of particles(≥10 μm) exceed the number of regulation.
Key words: nicorandil; drug stability; , drug carriers; chromatography, high pressure liquid
LIU Jian, LIU Xuerei, ZHANG Yakun. Study on stability of refrigerated drug Nicorandil compatible with solvents of different carriers[J]. Journal of Hebei Medical University, doi: 10.3969/j.issn.10073205.2019.05.022.
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URL: https://xuebao.hebmu.edu.cn/EN/10.3969/j.issn.10073205.2019.05.022
https://xuebao.hebmu.edu.cn/EN/Y2019/V40/I5/587