A. Karunakaran, V. Jaganathan, A. Subramanian
Jan 2, 2017
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Journal
Analytical Chemistry Letters
Abstract
Abstract In the present analytical study a rapid, robust and specific UPLC method has been developed and validated for Aliskiren hemifumarate and Hydrochlorothiazide in bulk and in combined tablet dosage form and it was applied to the dissolution study of Aliskiren hemifumarate and Hydrochlorthiazide. The separation was carried out on acquality UPLC HSS T3 100 mm×2.1, 1.8 μ column, using the mobile phase containing 0.1% Trifluoro acetic acid in water : Acetonitrile in the ratio of (75:25% v/ v) and at a flow rate of 0.4 ml / min and column temperature of 30°C. The UV detection was performed at 275 nm. The method developed for Aliskiren hemifumarate and Hydrochlorthiazide was found to be linear in the concentration range of 80 - 480 μg/ ml and 6 - 40 μg/ ml and correlation coefficient was found to be 0.9999 for both drugs. In accuracy the % recovery for Aliskiren hemifumarate and Hydrochlorthiazide was found to be 98.39 - 100.86% and 98.40 - 99.67%, respectively. The method was validated as per ICH guidelines. All the validation parameters were within the acceptance range. The development method can be successfully employed for the routine analysis of Aliskiren hemifumarate and Hydrochlorthiazide. Also the method was applied for the simultaneous estimation of Aliskiren hemifumarate and Hydrochlorthiazide in the sample collected from dissolution studies.