Abstract

Background

The advantages of simultaneous analyses are a decrease in analysis time and a more economical use of solvents and reagents. It is desirable that HPLC analyses possess both short term and good resolution.

Objective

The aim of the current study is to develop an HPLC method for the simultaneous determination of ibuprofen, sodium benzoate, methyl paraben and propyl paraben as preservatives, and sunset yellow as a colorant, in syrup formulation.

Method

To optimize chromatographic separation conditions, multi-response optimization using the Derringer’s desirability function was employed for the development of a rapid and efficient HPLC method. The ranges of independent variables used for the optimization process were 50–60% (v/v) for acetonitrile, 5.0–7.0 for pH, and 1.0–2.0 mL/min for flow rate of the mobile phase. The effects of these variables on the output responses, such as critical resolution between sunset yellow and sodium benzoate and retention time of the last peak indicating analysis time of the method, were evaluated by statistical experimental design.

Results

Optimum conditions fixed for the simultaneous analyses were acetonitrile:phosphate buffer (60:40, v/v), pH 5.0, and a flow rate of 1.8 mL/min. The eluate was monitored using a photo diode detector set at 220 nm. Total chromatographic analysis time was approximately 3 min.

Conclusions

The developed method validated as per International Conference on Harmonization guidelines was successfully applied for the determination of five compounds in their pharmaceutical formulation.

Highlights

This efficient method has isocratic elution system and can be used for routine analyses of these compounds in similar pharmaceutical products.

中文翻译：

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高效液相色谱法同时测定糖浆配方中布洛芬和添加剂的Box-Behnken设计-期望函数法

抽象的

背景

同步分析的优点是减少了分析时间，更经济地使用了溶剂和试剂。HPLC分析同时具有短期和良好的分离度是合乎需要的。

客观的

本研究的目的是开发一种同时测定糖浆制剂中布洛芬，苯甲酸钠，对羟基苯甲酸甲酯和对羟基苯甲酸丙酯作为防腐剂，日落黄作为着色剂的高效液相色谱法。

方法

为了优化色谱分离条件，采用了Derringer的合意函数进行多响应优化，以开发一种快速高效的HPLC方法。用于优化过程的自变量范围是：乙腈为50-60％（v / v），pH为5.0-7.0，流动相流速为1.0-2.0 mL / min。通过统计实验设计评估了这些变量对输出响应的影响，例如日落黄和苯甲酸钠之间的临界分辨率和指示方法分析时间的最后一个峰的保留时间。

结果

固定用于同步分析的最佳条件是乙腈：磷酸盐缓冲液（60:40，v / v），pH 5.0和1.8 mL / min的流速。使用设置为220 nm的光电二极管检测器监控洗脱液。总色谱分析时间约为3分钟。

结论

经国际协调会议指南验证的已开发方法已成功用于测定其药物制剂中的五种化合物。

强调

这种高效的方法具有等度洗脱系统，可用于对类似药物产品中的这些化合物进行常规分析。