用于测定两种药物剂型中对乙酰氨基酚与丹曲林或/和西替利嗪及伪麻黄碱的稳定性指示反相高效液相色谱法的开发与验证
Development and validation of a stability-indicating RP-HPLC method for the determination of paracetamol with dantrolene or/and cetirizine and pseudoephedrine in two pharmaceutical dosage forms.
作者信息
Hadad Ghada M, Emara Samy, Mahmoud Waleed M M
机构信息
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Suez Canal University, Ismailia 41522, Egypt.
出版信息
Talanta. 2009 Oct 15;79(5):1360-7. doi: 10.1016/j.talanta.2009.06.003. Epub 2009 Jun 9.
A stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method has been developed which can separate and accurately quantitate paracetamol, dantrolene, cetirizine and pseudoephedrine. The method was successfully validated for the purpose of conducting stability studies of the four analytes in quality control (QC) laboratories. The stability-indicating capability of the method was demonstrated by adequate separation of these four analytes from all the degradant peaks. A gradient mobile phase system consisting of (A) 50 mmol L(-1) sodium dihydrogen phosphate, 5 mmol L(-1) heptane sulfonic acid sodium salt, pH 4.2 and (B) acetonitrile was used with Discovery reversed-phase HS C(18) analytical column (250 mm x 4.6 mm i.d., 5 microm particle size). Quantitation was achieved with UV detection at 214 nm, based on peak area. The proposed method was validated and successfully applied for the analysis of pharmaceutical formulations and laboratory-prepared mixtures containing the two multicomponent combinations.
已开发出一种稳定性指示反相高效液相色谱（RP-HPLC）方法，该方法可分离并准确定量对乙酰氨基酚、丹曲林、西替利嗪和伪麻黄碱。该方法已成功验证，可用于质量控制（QC）实验室对这四种分析物进行稳定性研究。通过将这四种分析物与所有降解峰充分分离，证明了该方法的稳定性指示能力。使用由（A）50 mmol L（-1）磷酸二氢钠、5 mmol L（-1）庚烷磺酸钠盐、pH 4.2和（B）乙腈组成的梯度流动相系统，搭配Discovery反相HS C（18）分析柱（250 mm×4.6 mm内径，5微米粒径）。基于峰面积，通过在214 nm处进行紫外检测实现定量。所提出的方法经过验证，并成功应用于含有两种多组分组合的药物制剂和实验室制备混合物的分析。
Zotero 插件