Analytical method development and validation for the estimation of Aliskiren Hemifumarate and Hydrochlorothiazide in bulk and pharmaceutical dosage form

Abstract

A simple, accurate, precise and sensitive UV spectrophotometry method namely absorption ratio and RP-HPLC methods have been developed and validated for estimation of Aliskiren Hemifumarate and Hydrochlorothiazide in combined tablet dosage form and can be used in routine analysis. In UV spectrophotometry method namely absorbance ratio method, absorbance measured at iso-absorptive point 275 nm (correlation coefficient was found to be 0.999 and 0.997 for Aliskiren Hemifumarate and Hydrochlorothiazide respectively) and 270 nm (correlation coefficient was found to be 0.999 and 0.997 for Aliskiren Hemifumarate and Hydrochlorothiazide respectively). Assay was found to be 102.86% and 97.60% for Aliskiren Hemifumarate and Hydrochlorothiazide respectively. The methods were found to be linear in the concentration range of 20-70μg/mL and 2.5-12.5μg/mL for Aliskiren Hemifumarate and Hydrochlorothiazide respectively. A simple, accurate, precise and sensitive UV spectrophotometry method namely absorption ratio and RP-HPLC methods have been developed and validated for estimation of Aliskiren Hemifumarate and Hydrochlorothiazide in combined tablet dosage form and can be used in routine analysis. In UV spectrophotometry method namely absorbance ratio method, absorbance measured at iso-absorptive point 275 nm (correlation coefficient was found to be 0.999 and 0.997 for Aliskiren Hemifumarate and Hydrochlorothiazide respectively) and 270 nm (correlation coefficient was found to be 0.999 and 0.997 for Aliskiren Hemifumarate and Hydrochlorothiazide respectively). Assay was found to be 102.86% and 97.60% for Aliskiren Hemifumarate and Hydrochlorothiazide respectively. The methods were found to be linear in the concentration range of 20-70μg/mL and 2.5-12.5μg/mL for Aliskiren Hemifumarate and Hydrochlorothiazide respectively.