论文总字数：18613字

摘 要

目的：本论文设置了盐酸右美托咪定注射液含量的测量方式，利用高效液相色谱法对dexmedetomidine hydrochloride进行方法学考察和含量测定。色谱条件为：使用Inertsustain C₁₈（4.6*250mm，5µm）色谱柱，检测波长为220nm，进样体积控制为20µL每次。流动相A相：B相=35：65，A相为乙腈，B相为0.03mol/L磷酸二氢钾溶液（精密称取磷酸二氢钾4.08g，加适量水溶解，加三乙胺2.0mL，用水稀释至1000mL）。用0.9%氯化钠注射液作为稀释液使用，用甲醇-水（50:50）作为洗针液。流速控制为1.0mL/min，运行时间为25min。结果表明dexmedetomidine hydrochloride在0.1μg/mL-204.73μg/mL容量程度内与其Peak area呈良好的线性关系，其Linear equation为：y = 78723x 16094，R² = 0.9999。盐酸右美托咪定供试品溶液在室温20h内的稳定性良好,测得RSD为0.14%，表明进样精密度良好；相对标准偏差为0.07%，重复性良好；回收率为90%-110%。由此得到结论：该分析方法简单高效、精准无误、敏锐度好、精密度好，适用于盐酸右美托咪定注射液的含量测定。

关键词:高效液相色谱法 盐酸右美托咪定注射液 方法学研究 含量测定

Determination of the content of dexmedetomidine hydrochloride injection

Abstract

Objective: In the essay, the test way of dexmedetomidine hydrochloride injection was built. Employing high performance liquid chromatography ，the methodological investigation and content judgment of dexmedetomidine hydrochloride were carried out . The liquid phase method: Use Inertsustain C₁₈ (4.6*250mm, 5μm) column, detection wavelength is 220nm. Each injection volume is 20μL, mobile phase A phase: B phase = 35:65. Phase A is acetonitrile, phase B is 0.03mol/L potassium dihydrogen phosphate solution (take potassium dihydrogen phosphate 4.08g, increase right amount of water to dissolve, increase triethylamine 2.0mL, diluted with water to 1000mL). Use 0.9% sodium chloride injection as a diluent, use methanol-water (50:50) as a washing solution. The flow rate was controlled to 1.0 mL/min and the run time was 25 min. The results indicated that dexmedetomidine hydrochloride indicated the beautiful linear relationship with the summit acreage in the consistence scope of 0.1μg/mL~204.73μg/mL. The linear equation is: y = 78723x 16094, R² = 0.9999. The dexmedetomidine hydrochloride standard and the test solution have good stability at room temperature for 20 hours, and the RSD is 0.14%. The precision is good , and the RSD is 0.07%. The recovery rate is 90%-110%. The repeatability is good, and the RSD is 0.07%. The conclusion is as follows: the analysis method is simple, rapid, accurate, reliable, high sensitivity and good precision, and is suitable for the determination of dexmedetomidine hydrochloride injection.

Key words: High performance liquid chromatography Dexmedetomidine hydrochloride injection Methodological research Content determination

目录

摘要 I

Abstract II

第一章 盐酸右美托咪定注射液的综述 1

1.1右美托咪定 1

1.1.1盐酸右美托咪定的基本信息 1

1.1.2药理作用 1

1.1.3 临床应用 2

1.1.4 盐酸右美托咪定的测定仪器 3

1.2 研究依据与目的 4

第二章 盐酸右美托咪定注射液的含量测定 5

2.1 仪器与试剂 5

2.1.1 仪器 5

2.1.2 试剂 5

2.1.3 供试品与对照品 5

2.2 测定方法 6

2.2.1 溶液的准备 6

2.2.2 色谱条件 7

2.3 方法学研究 8

2.3.1 专属性实验 8

2.3.2 线性研究 8

2.3.3进样精密度研究 9

2.3.4 重复性研究 10

2.3.5回收率研究 11

2.3.6进样对照品溶液稳定性研究 12

2.3.7进样供试品溶液稳定性研究 12

2.3.8高低浓度制剂稳定性研究 12

2.4含量测定 13

2.5 讨论 14

2.6 小结 15

第三章 结论与展望 16

3.1 结论 16

3.2 展望 16

参考文献 17

致 谢 20

第一章 盐酸右美托咪定注射液的综述

1.1右美托咪定

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