In Vitro Comparison of Different Brands of Cetirizine 2HCl Tablets by Spectroscopy and Thin Layer Chromatography (TLC) in Local Market of Lahore, Pakistan

S. Mahmood, A. Rafiq, Zaheer Ahmad, M. Ajmal
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Abstract

The objective of the present study is to investigate and compare the efficacy, physiochemical equivalence and purity of API’s of different brands of cetirizine 2HCl tablets (10mg) with that of multinational brands available in local market of Lahore, Pakistan. The present work also provides awareness to allergy patients about most effective local brands with reasonable prices, without any health risk. Spectrophotometric method is used for chemical assay, TLC technique is subjected for the purity of API’s and physiochemical parameters is employed i.e. weight variation, hardness, friability, thickness, disintegration time and dissolution study as well as price fluctuation in PK rupees. The results of all physiochemical parameters and chemical assay are found to be within limit and meet to the pharmacopeial standards. TLC technique is developed to check the quality and purity of API, all the active ingredients showed the similar Rf -values without any impurity (0.38-0.39). From the test results and plots, it is observed and concluded that an economical and quality products can be prescribed for allergy patients whether they are manufactured by the local or multinational pharmaceutical companies without any health risk.
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巴基斯坦拉合尔当地市场不同品牌西替利嗪2HCl片的光谱法和薄层色谱法体外比较
本研究的目的是调查和比较不同品牌西替利嗪2HCl片(10mg)与巴基斯坦拉合尔当地市场上的跨国品牌API的疗效、理化等效性和纯度。目前的工作还让过敏患者了解最有效的当地品牌,价格合理,没有任何健康风险。采用分光光度法进行化学分析,采用薄层色谱法测定API的纯度,并采用理化参数,即重量变化、硬度、脆性、厚度、崩解时间和溶解研究以及PK卢比的价格波动。所有理化参数和化学分析结果均在限值范围内,符合药典标准。采用薄层色谱法检测API的质量和纯度,所有活性成分的Rf-值相似,无任何杂质(0.38-0.39),观察并得出结论,无论是由当地还是跨国制药公司生产的,都可以为过敏患者开出经济、优质的产品,而不会对健康造成任何风险。
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