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Abstract

A Simple And Sensitive HPTLC For The Determination Of Content Uniformity Of Atorvastatin Calcium Tablets

Author(s): Savita S Yadav, Deepali V Mhaske, A. B Kakad, B. D Patil, S. S Kadam, S. R Dhaneshwar

A simple, sensitive HPTLC method was developed for the analysis of atorvastatin calcium in its commercial single component tablet formulations (10 mg/tablet). The stationary phase was precoated silica gel 60 F254. The mobile phase used was a mixture of benzene: methanol, (7:3 v/v). Combination of benzene: methanol offered optimum migration (RF=0.46±0.02). Detection of the spots was carried out at 281 nm. The method was validated in terms of linearity (200-600 ng/spots), precision (intra-day variation: 0.25 to 1.01%, inter-day variation: 0.21 to 0.88%), accuracy (99.2±0.48) and specificity. The limit of detection and limit of quantification for atorvastatin calcium were found to be 40 ng/spot and 200 ng/spot, respectively. The proposed method was successfully applied to determine atorvastatin calcium content of 10 individual tablet units o f two market formulations, after extracting atorvastatin calcium with methanol. Both the formulation complied with the USP specifications (RSD less than or equal to 6 %) of the content uniformity test. The proposed HPTLC method can analyse ten or formulation units simultaneously on a single plate and provides a faster and cost-effective quality control tool for routine analysis of atorvastatin calcium tablet formulation.