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

摘要

Objective: A new, simple, selective, and reproducible stability indicating reversed - phase high performance liquid chromatography method for the simultaneous estimation of Aliskiren (ALN) Hemifumarate and Valsartan (VLN) in bulk drug, and tablet dosage form was developed and validated as per ICH guidelines. Methods: The chromatographic separation was performed using a nucleosil C - 18 column and the analytes were detected by a malondialdehyde - 2010 photodiode array detector. The mobile phase composed of methanol: potassium dihydrogen ortho phosphate buffer (adjusted to pH 3 with orthophosphoric 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 be 5-50 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 of 99.95% 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 and VLN in bulk and tablet dosage form as per regulatory requirements.