Journal of Hebei Medical University

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Study on stability of refrigerated drug Nicorandil compatible with solvents of different carriers

  

  1. Department of Pharmacy, the Second Hospital of Hebei Medical University, Shijiazhuang 050000, China
  • Online:2019-05-25 Published:2019-05-22

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 ultrahigh performance liquid chromatography, and the chromatographic conditions were as follows: chromatographic column was ACEC18(50 mm×2.1 mm, 2.5 μm) column and the column temperature was 40 ℃, the mobile phase was methanolwater(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