Suppr超能文献

连续比例减法结合恒乘法分光光度法测定复方制剂中对苯二酚及其降解产物维甲酸和对羟基苯甲酸甲酯的含量

Successive ratio subtraction coupled with constant multiplication spectrophotometric method for determination of hydroquinone in complex mixture with its degradation products, tretinoin and methyl paraben.

作者信息

Elghobashy Mohamed R, Bebawy Lories I, Shokry Rafeek F, Abbas Samah S

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., 11562 Cairo, Egypt.

National Organization for Drug Control and Research (NODCAR), 51 Wezaret El-Zeraa St. Dokki, Cairo, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2016 Mar 15;157:116-123. doi: 10.1016/j.saa.2015.12.019. Epub 2015 Dec 19.

Abstract

A sensitive and selective stability-indicating successive ratio subtraction coupled with constant multiplication (SRS-CM) spectrophotometric method was studied and developed for the spectrum resolution of five component mixture without prior separation. The components were hydroquinone in combination with tretinoin, the polymer formed from hydroquinone alkali degradation, 1,4 benzoquinone and the preservative methyl paraben. The proposed method was used for their determination in their pure form and in pharmaceutical formulation. The zero order absorption spectra of hydroquinone, tretinoin, 1,4 benzoquinone and methyl paraben were determined at 293, 357.5, 245 and 255.2 nm, respectively. The calibration curves were linear over the concentration ranges of 4.00-46.00, 1.00-7.00, 0.60-5.20, and 1.00-7.00 μg mL(-1) for hydroquinone, tretinoin, 1,4 benzoquinone and methyl paraben, respectively. The pharmaceutical formulation was subjected to mild alkali condition and measured by this method resulting in the polymerization of hydroquinone and the formation of toxic 1,4 benzoquinone. The proposed method was validated according to ICH guidelines. The results obtained were statistically analyzed and compared with those obtained by applying the reported method.

摘要

研究并开发了一种灵敏且具选择性的稳定性指示连续比率减法结合恒乘法(SRS-CM)分光光度法,用于不经预先分离的五组分混合物的光谱解析。这些组分包括对苯二酚与维甲酸、对苯二酚碱降解形成的聚合物、1,4-苯醌以及防腐剂对羟基苯甲酸甲酯。所提出的方法用于它们纯品形式及药物制剂中的测定。对苯二酚、维甲酸、1,4-苯醌和对羟基苯甲酸甲酯的零阶吸收光谱分别在293、357.5、245和255.2 nm处测定。对苯二酚、维甲酸、1,4-苯醌和对羟基苯甲酸甲酯的校准曲线在浓度范围分别为4.00 - 46.00、1.00 - 7.00、0.60 - 5.20和1.00 - 7.00 μg mL⁻¹时呈线性。将药物制剂置于温和碱性条件下并用该方法测定,结果导致对苯二酚聚合并形成有毒的1,4-苯醌。所提出的方法根据国际人用药品注册技术协调会(ICH)指南进行了验证。对获得的结果进行了统计分析,并与应用报道方法获得的结果进行了比较。

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验