Quantitative Simultaneous Determination of Aliskiren Hemifumarate and Hydrochlorothiazide in Combined Tablet Formulation by Rp-Hplc

Abstract

Objective: Development and validation of quantitative simultaneous determination of aliskiren hemifumarate (ALI) and hydrochlorothiazide (HCT) in combined tablet formulation by RP-HPLC. Methods: The separation of components were achieved on Enable C18 column (250×4.6 mm, 5 μm) with a mobile phase consisting of 0.2 %v/v triethylamine in water (pH 6 was adjusted with orthophosphoric acid): methanol (10:90 %v/v) at a flow rate of 1 ml/min was employed. Quantification was achieved with PDA detection at 280 nm. Validation parameters of the proposed method such as specificity, linearity, accuracy, precision and robustness were evaluated according to ICH guidelines. Results: Linear concentration range was between 1.2-240 μg/ml for ALI and 0.1-20 μg/ml for HCT and correlation coefficient was found to be 0.9995 and 0.9998, respectively. The limit of detection and limit of quantification for ALI was found to be 0.3376 and 1.0230 μg/ml and for HCT 0.0288 and 0.0873 μg/ml, respectively. The results of precision (% RSD<2) studies showed good reproducibility. Recovery study was performed at 50, 100 and 150 % level to check the interferences between analytes and formulation excipients and % recovery was found to be 99.49±0.9868 for ALI and 99.87±0.8556 for HCT. The percentage assay was found to be 100.36±0.9201 and 99.40±0.7624 for ALI and HCT, respectively. Conclusion: A simple, rapid, cost effective and highly sensitive RP-HPLC method as compared to existing methods for the determination of ALI and HCT in tablet formulation was developed and validated as per ICH guidelines. The method uses simple reagents and sample preparation procedures were minimal. Thus, the proposed method can be applied for routine quality control determination