不同紫外分光光度法在分析阿考替胺和埃索美拉唑中的应用。

Application of Different UV Spectrophotometric Methods for Quantitative Analysis of Acotiamide and Esomeprazole.

机构信息

Al-Azhar University, Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, 11751 Nasr City, Cairo, Egypt.

Damanhour University, Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beheira, Egypt.

出版信息

J AOAC Int. 2022 Sep 6;105(5):1475-1478. doi: 10.1093/jaoacint/qsac041.

DOI:10.1093/jaoacint/qsac041

PMID:35353147

Abstract

BACKGROUND

Acotiamide and esomeprazole are co-administrated and prescribed for gastrointestinal disorder diseases.

OBJECTIVE

Development of the first UV spectrophotometric methods for the quantitative analysis of acotiamide and esomeprazole in their mixture.

METHODS

The UV absorption spectra of acotiamide and esomeprazole showed severe overlapping. To solve the spectral overlapping and quantify the studied drugs in their mixture, simultaneous equation and ratio difference methods were developed. For simultaneous equation method, the absorbance and absorptivity values at 279 and 302 nm were used to construct two mathematical equations applied for the spectrophotometric assay of the cited drugs. Ratio difference spectra manipulated method was developed and enabled successful quantitative determination of acotiamide and esomeprazole. The differences in the amplitude values between 280 and 260 nm enabled estimation of acotiamide, and the differences in the amplitude values between 303 and 282 nm enabled estimation of esomeprazole.

RESULTS

The proposed methods succeeded to quantify acotiamide and esomeprazole in the synthetic mixtures and in their pharmaceutical tablets without any interference from each other or from tablet additives.

CONCLUSIONS

The applied methods demonstrated good linearity in the concentration range of 2-30 µg/mL and 2-20 µg/mL for acotiamide and esomeprazole, respectively, with acceptable accuracy and precision. The methods were found to be sensitive with LOD values of 0.336 µg/mL and 0.332 µg/mL for acotiamide and esomeprazole, respectively, in simultaneous equation method and of 0.410 µg/mL and 0.333 µg/mL for acotiamide and esomeprazole, respectively, in ratio difference method.

HIGHLIGHTS

Simple and validated UV spectrophotometric methods were described for selective quantification of the acotiamide and esomeprazole in their mixture.

摘要

背景

阿考替胺和埃索美拉唑联合用于治疗胃肠道疾病。

目的

建立同时测定阿考替胺和埃索美拉唑的紫外分光光度法。

方法

阿考替胺和埃索美拉唑的紫外吸收光谱严重重叠。为了解决光谱重叠问题并对混合物中的两种药物进行定量分析，建立了同时方程和比值差法。对于同时方程法，采用 279nm 和 302nm 的吸光度和吸光系数值构建两个数学方程，用于分光光度法测定这两种药物。比值差光谱处理法也被开发出来，成功地对阿考替胺和埃索美拉唑进行了定量测定。在 280nm 与 260nm 之间的振幅差值可用于估算阿考替胺的浓度，在 303nm 与 282nm 之间的振幅差值可用于估算埃索美拉唑的浓度。

结果

该方法成功地对合成混合物及片剂中的阿考替胺和埃索美拉唑进行了定量分析，且彼此之间及与片剂辅料之间无干扰。

结论

所应用的方法在阿考替胺和埃索美拉唑的浓度范围分别为 2-30μg/mL 和 2-20μg/mL 时具有良好的线性，且准确度和精密度均令人满意。在同时方程法中，阿考替胺和埃索美拉唑的检测限分别为 0.336μg/mL 和 0.332μg/mL，在比值差法中，阿考替胺和埃索美拉唑的检测限分别为 0.410μg/mL 和 0.333μg/mL，表明该方法具有较高的灵敏度。