一种用于测定药物剂型中西替利嗪含量的高效液相色谱法的开发与验证
Development and validation of a HPLC method for the determination of cetirizine in pharmaceutical dosage forms.
作者信息
Paw B, Misztal G, Hopkała H, Drozd J
机构信息
Medical University of Lublin, Faculty of Pharmacy, Department of Medicinal Chemistry, Lublin, Poland.
出版信息
Pharmazie. 2002 May;57(5):313-5.
A rapid, simple and accurate HPLC method is described for the assay of cetirizine in commercial dosage forms. Methanol was found to be a suitable extraction solvent for tablets and for preparing solutions from drops and oral liquids. The samples were chromatographed on a Nova-Pak C18 column and UV detected at 227 nm. The elution was achieved isocratically with a mobile phase of 0.067 M phosphate buffer pH 3.40/acetonitrile (1:1, v/v). Ketotifen was applied as an internal standard. The method was validated for linearity, precision, accuracy and limit of detection. The recovery (mean +/- SD) for tablets was 100.88% +/- 0.8967, for drops 100.35% +/- 0.4062 and for solutions 101.20% +/- 1.1698.
本文描述了一种快速、简单且准确的高效液相色谱法，用于测定市售剂型中西替利嗪的含量。结果发现甲醇是片剂的合适提取溶剂，也是制备滴剂和口服液溶液的合适溶剂。样品在Nova-Pak C18柱上进行色谱分析，并在227 nm处进行紫外检测。采用0.067 M pH 3.40的磷酸盐缓冲液/乙腈（1:1，v/v）作为流动相进行等度洗脱。以酮替芬作为内标。该方法在线性、精密度、准确度和检测限方面均得到验证。片剂的回收率（平均值±标准差）为100.88%±0.8967，滴剂为100.35%±0.4062，溶液为101.20%±1.1698。
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