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Ultra Performance Liquid Chromatographic Method for the Determination of Cetirizine Dihydrochloride in Commercial Pharmaceutical Liquid Formulation

机译:超高效液相色谱法测定商品药液中盐酸西替利嗪的含量

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摘要

A new ultra performance liquid chromatographic method was developed for the determination of cetirizine hydrochloride in pharmaceutical liquid formulation. The chromatographic separation was achieved on aquity ultra performance liquid chromatographic BEH C_(18) (100 x 2.1 mm, 1.7 μm) column and a mobile phase consisting of a water:acetonitrile (50:50, v/v). The flow rate was 0.3 mL rain~(-1) and the detection wavelength was 235 nm. The ultra performance liquid chromatographic method shows excellent linearity over a range of 4 μg mL~(-1) to 28 μg mL~(-1). The correlation coefficient for the cetirizine hydrochloride the linear regression equation was more than 0.999, The limit of detection and the limit of quantification for cetirizine hydrochloride were found as 0.39 and 1.30 μg mL~(-1), respectively. This chromatographic method was validated by using validation parameters. The proposed chromatographic method can be applied to the quality control and routine analysis of cetirizine hydrochloride in pharmaceutical liquid formulation.
机译:建立了一种新的超高效液相色谱法,用于测定药物液体制剂中盐酸西替利嗪。色谱分离是在大量超高效液相色谱BEH C_(18)(100 x 2.1 mm,1.7μm)色谱柱和由水:乙腈(50:50,v / v)组成的流动相上完成的。流速为0.3mL雨水(-1),检测波长为235nm。超高效液相色谱法在4μgmL〜(-1)至28μgmL〜(-1)范围内显示出优异的线性。盐酸西替利嗪线性回归方程的相关系数大于0.999,盐酸西替利嗪的检出限和定量限分别为0.39和1.30μgmL〜(-1)。该色谱方法通过使用验证参数进行验证。所提出的色谱方法可用于西替利嗪盐酸盐在液体制剂中的质量控制和常规分析。

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