论著

紫外可见分光光度法测定盐酸法舒地尔注射液中盐酸法舒地尔的含量

吕洁1 孟祥军1* 邹春阳2

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【摘要】  目的 建立紫外-可见分光光度(UV-VIS)法测定盐酸法舒地尔含量的方法。方法 采用对照品法,检测波长为275nm。结果 制剂中辅料对主药测定无干扰,UV-VIS 法测定盐酸法舒地尔的质量浓度在24~36μg/mL 范围内线性关系良好(r 2=0.9999)。

【关键字】  紫外- 可见分光光度法,盐酸法舒地尔注射液,含量测定

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[Abstract] Objective Ultraviolet-visible spectrophotometry (UV-VIS) was established to determine the fasudil hydroehloride content in the fasudil hydroehloride injection. Methods Reference standard method (λ-275nm) was used to determine the content of fasudil hydroehloride. Results The test of fasudil hydroehloride was 1inear within the range of 24~36μg/mL, r 2=0.9999. The average recovery was 99.3%, RSD=0.29%. Conclusion The methods were simple and accurate, and the methods were suitable to determine the content.

    盐酸法舒地尔(fasudil hysrochloride)是日本Asahi Chemical公司1994年上市的商品名为Eril的新型的钙拮抗的血管扩张剂,临床用于治疗脑血管痉挛引发的蛛网膜下出血。本品用于治疗急性缺血性中风、脑血管疾病和心绞痛后遗症正在临床试验中[1]。它的分子结构为5-异喹啉磺酰胺衍生物[2]。本研究参考新药转正标准WS1-(X-110)-2006Z盐酸法舒地尔及相关文献[3,4],建立了紫外-可见分光光度(UV-VIS)法测定盐酸法舒地尔注射液含量的方法,通过方法学验证,本方法准确、简便、专属性强,重复性好,能够满足控制本品含量的要求。

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