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一种快速灵敏的反相高效液相色谱法,用于同时测定药物样品中的布洛芬和扑热息痛及其在模拟胃液条件下的行为。

A rapid and sensitive reversed phase-HPLC method for simultaneous determination of ibuprofen and paracetamol in drug samples and their behaviors in simulated gastric conditions.

机构信息

Department of Chemistry, Yıldız Technical University, İstanbul, Turkey.

Department of Chemical Engineering, Yıldız Technical University, İstanbul, Turkey.

出版信息

J Sep Sci. 2019 Feb;42(3):678-683. doi: 10.1002/jssc.201801002. Epub 2018 Dec 6.

Abstract

Paracetamol is a widely used drug for fever and pain relief. Ibuprofen is a common nonsteroidal anti-inflammatory drug. In this study, a sensitive and accurate reversed phase high performance liquid chromatography method was developed for the simultaneous determination of ibuprofen and paracetamol. The chromatographic separation was achieved on a Phenomenex C18 (250 mm, 4.6 mm, 5 μm) column. Fifty milli molar phosphate buffer (pH 7.5) and methanol were used as mobile phase in a gradient elution mode. The retention times of paracetamol and ibuprofen were 5.7 and 10.4 min, respectively. The linearity of the developed method was established in the range of 0.25 - 250 mg/L with a correlation coefficient of 0.9998 for both analytes. The limit of detection/quantification values were found to be 0.06/0.19 and 0.08/0.26 mg/L for ibuprofen and paracetamol, respectively. The method was successfully applied in drug samples in the form of tablets and suspensions. The calculated concentrations matched with the claimed values on their prospectuses. The drug samples were studied under simulated gastric conditions to determine the behaviors of the analytes in the human body. The obtained results showed no change in the retention time of the analyte peak shapes throughout the 210 minutes.

摘要

对乙酰氨基酚是一种广泛用于退烧和止痛的药物。布洛芬是一种常见的非甾体抗炎药。在这项研究中,开发了一种灵敏准确的反相高效液相色谱法,用于同时测定布洛芬和对乙酰氨基酚。色谱分离在 Phenomenex C18(250mm,4.6mm,5μm)柱上进行。50 毫摩尔磷酸盐缓冲液(pH7.5)和甲醇以梯度洗脱模式作为流动相。对乙酰氨基酚和布洛芬的保留时间分别为 5.7 和 10.4 分钟。所开发方法的线性范围为 0.25-250mg/L,两种分析物的相关系数均为 0.9998。布洛芬和对乙酰氨基酚的检测限/定量限分别为 0.06/0.19 和 0.08/0.26mg/L。该方法成功应用于片剂和混悬剂形式的药物样品。计算出的浓度与说明书上的宣称值相符。对药物样品进行模拟胃条件下的研究,以确定分析物在人体中的行为。获得的结果表明,在 210 分钟内,分析物峰形的保留时间没有变化。

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