星点设计-效应面法优化苦参碱氯化钠注射液有关物质检查方法

顾小燕; 狄斌; 陈民辉; 李耕; 黄青; 严菲; 曹玲

引用本文:	顾小燕,狄斌,陈民辉,李耕,黄青,严菲,曹玲.星点设计-效应面法优化苦参碱氯化钠注射液有关物质检查方法[J].中国现代应用药学,2022,39(3):358-363.
	GU Xiaoyan,DI Bin,CHEN Minhui,LI Geng,HUANG Qing,YAN Fei,CAO Ling.Optimization for the Method of Related Substances Determination of Matrine and Sodium Chloride Injection by Central Composite Design-response Surface Method[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(3):358-363.

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星点设计-效应面法优化苦参碱氯化钠注射液有关物质检查方法
顾小燕^1,2, 狄斌², 陈民辉¹, 李耕¹, 黄青¹, 严菲¹, 曹玲¹
1.江苏省食品药品监督检验研究院, 南京 210019;2.中国药科大学, 南京 211198

摘要:

目的采用星点设计-效应面法优化苦参碱氯化钠注射液有关物质检查的色谱条件。方法以流动相pH、乙腈比例和柱温为考察因素，以保留时间、分离度以及理论板数为考察指标，进行标准归一化和多元线性回归，运用效应面法获取最优色谱条件并进行方法学验证。结果确定了最优色谱条件，流动相为0.2%的三乙胺溶液（磷酸调节pH值至6.5）-乙腈（90：10），柱温为40℃。结论星点设计-效应面法优选出的色谱条件可用于苦参碱氯化钠注射液的有关物质检查，且方法准确度高、重复性好。

关键词: 星点设计-效应面法高效液相色谱法苦参碱氯化钠注射液有关物质

DOI：10.13748/j.cnki.issn1007-7693.2022.03.012

分类号:R927.11

基金项目:

Optimization for the Method of Related Substances Determination of Matrine and Sodium Chloride Injection by Central Composite Design-response Surface Method

GU Xiaoyan^1,2, DI Bin², CHEN Minhui¹, LI Geng¹, HUANG Qing¹, YAN Fei¹, CAO Ling¹

1.Jiangsu Institute of Food and Drug Control, Nanjing 210019, China;2.China Pharmaceutical University, Nanjing 211198, China

Abstract:

OBJECTIVE To optimize the chromatographic conditions for detecting related substances of Matrine and Sodium Chloride Injection by using central composite design-response surface method. METHODS The pH of the mobile phase, the proportion of acetonitrile in the mobile phase and the column temperature were taken as investigation factors, and the retention time, resolution and the number of theoretical plates served as inspection indexes. The study carried out standard normalization and multiple linear regression, and used response surface method to obtain optimal chromatographic conditions. The methodology was verified. RESULTS The optimal chromatographic conditions were determined, the mobile phase was 0.2% triethylamine aqueous solution(adjusted pH to 6.5 with phosphoric acid)-acetonitrile(90:10), and the column temperature was 40℃. CONCLUSION The chromatographic conditions optimized by central design-response surface method can be used for the determination of related substances in Matrine and Sodium Chloride Injection. The method has high accuracy and good repeatability.

Key words: central composite design-response surface method HPLC Matrine and Sodium Chloride Injection related substance