DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ALISKIREN HEMIFUMARATE AND VALSARTAN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Abstract

Objective: A new, simple, selective, and reproducible stability indicating reversed - phase high performance liquid chromatography method for thesimultaneous estimation of Aliskiren (ALN) Hemifumarate and Valsartan (VLN) in bulk drug, and tablet dosage form was developed and validated asper ICH guidelines.Methods: The chromatographic separation was performed using a nucleosil C - 18 column and the analytes were detected by a malondialdehyde - 2010photodiode array detector. The mobile phase composed of methanol: potassium dihydrogen ortho phosphate buffer (adjusted to pH 3 withorthophosphoric acid). The flow rate was set at 1 ml/minutes, and the detection was carried out at 225 nm.Results: ALN Hemifumarate and VLN showed a retention time of 3.84 and 5.96 minutes, respectively. The linear dynamic range was found to be5-50 mcg/ml and 5-30 mcg/ml with a co-relation co-efficient of 0.992 and 0.985 for ALN and VLN, respectively, with mean percentage recoveries of99.95% and 99.25%. The results were validated and were found to successfully obey the parameters as per ICH guidelines.Conclusion: Hence, the method can be successfully applied for routine quality control analysis and stability studies for both ALN Hemifumarate andVLN in bulk and tablet dosage form as per regulatory requirements.Keywords: Aliskiren Hemifumarate, Valsartan, Reversed-phase high performance liquid chromatography, Stress degradation study, ICH guidelines