Validated TLC-densitometry method for determination of cetirizine dihydrochloride in tablet dosage form

Nia Kristiningrum, Ellsy Novita Martyanti
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引用次数: 1

Abstract

A rapid, reproducible and accurate TLC method was developed for the determination of Cetirizine Dihydrochloride in tablet. The analytes were dissolved with ethanol 70% and chromatographed on silica Gel GF 254 TLC plate using chloroform : methanol : ethyl acetate in the ratio of 2 : 7 : 3 (v/v) as mobile phase. Quantitative analysis was done through densitometric measurement at wavelength 234 nm. Method was found linear over the concentration range of 400 – 1600 ng/spot with the correlation coefficient of 0.996. Specificity showed calculation of purity and identity more than 0.99. The limit of detection (LOD) and the limit of quantification (LOQ) of the method were 75.54 and 226.64 ng/spot. The relative standard deviation of this method was 0.86% whereas the means of the recovery data was 100.54 ± 0.11%. The proposed method has been applied to the determination of Cetirizine Dihydrochloride in commercial tablet formulations and the result were 96.97 ± 0.86 % for brand A and 100.57 ± 1.17 % for brand B. The developed method was successfully used for the assay of Cetirizine Dihydrochloride. This method is simple, sensitive and precise; it can be used for the routine quality control testing of marketed formulations. DOI:  http://dx.doi.org/10.3329/icpj.v3i1.17294 International Current Pharmaceutical Journal, December 2013, 3(1): 208-210
用薄层色谱密度法测定片剂中盐酸西替利嗪的含量
建立了一种快速、简便、准确的薄层色谱法测定盐酸西替利嗪片中盐酸西替利嗪的含量。用70%乙醇溶解,以氯仿:甲醇:乙酸乙酯,以2:7:3 (v/v)为流动相,在GF - 254硅胶薄层色谱板上进行色谱分析。通过波长234nm的密度测量进行定量分析。方法在400 ~ 1600 ng/点的浓度范围内呈线性,相关系数为0.996。特异性表明计算纯度和鉴定度均大于0.99。方法的检出限(LOD)和定量限(LOQ)分别为75.54和226.64 ng/点。方法的相对标准偏差为0.86%,回收率均值为100.54±0.11%。该方法已应用于盐酸西替利嗪市售片剂中盐酸西替利嗪的含量测定,A、b的含量测定结果分别为96.97±0.86%和100.57±1.17%,可用于盐酸西替利嗪的含量测定。该方法简便、灵敏、准确;它可用于上市制剂的常规质量控制测试。DOI: http://dx.doi.org/10.3329/icpj.v3i1.17294国际现代医药杂志,2013年12月,3(1):208-210
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