Abstract
The present study describes the stability indicating RP-HPLC method for simultaneous estimation of aliskiren hemifumarate and amlodipine besylate in pharmaceutical dosage forms. The proposed RP-HPLC method was developed by using waters 2695 separation module equipped with PDA detector and chromatographic separation was carried on C-8 Inertsil ODS (150 × 4.6 mm, 5 µ) column at a flow rate of 1 mL/min and the run time is 10 min. The mobile phase consisted of phosphate buffer and acetonitrile in the ratio of 40 : 60% v/v and pH was adjusted to 3 with orthophosphoric acid and eluents were scanned using PDA detector at 237 nm. The retention time of aliskiren and amlodipine was found to be 3.98 and 5.14 min, respectively. A linearity response was observed in the concentration range of 30–225 µg/mL for aliskiren and 2–15 µg/mL for amlodipine, respectively. Limit of detection and limit of quantification for aliskiren are 0.161 µg/mL and 0.489 µg/mL and for amlodipine are 0.133 µg/mL and 0.404 µg/mL, respectively. The stability indicating method was developed by subjecting the drugs to stress conditions such as acid and base hydrolysis, oxidation, and photo- and thermal degradation and the degraded products formed were resolved successfully from the samples.
Highlights
Aliskiren is a novel antihypertensive agent and is the first orally active rennin inhibitor indicated for the treatment of hypertension [1,2,3]
A series of trials was conducted with different columns like Inertsil ODS and agilent XDB C18 and C-8 columns with different mobile phases to develop a suitable RP-HPLC method for estimation of aliskiren hemifumarate and amlodipine besylate in tablet dosage form, and a typical chromatogram was obtained with phosphate buffer and acetonitrile in the ration of 40 : 60% v/v and pH was adjusted to 3 with orthophosphoric acid at a flow rate of 1 mL/min
The chromatographic separation was performed on C-8 Inertsil ODS (150 × 4.6 mm, 5 μ) by injecting 10 μL and analytes were detected with PDA detector at 237 nm
Summary
Aliskiren is a novel antihypertensive agent and is the first orally active rennin inhibitor indicated for the treatment of hypertension [1,2,3]. Amlodipine is a member of 1, 4-dihydropyridine class of calcium antagonist approved for the treatment of heart diseases like hypertension and angina pectoris. It is a long acting calcium channel blocker that inhibits the influx of calcium ions into the vascular smooth muscle and cardiac muscle [8, 9]. Through literature survey reveals that there are few analytical methods such as RP-HPLC [11, 12] and UV methods [13, 14] are reported for simultaneous estimation of aliskiren and amlodipine in pharmaceutical dosage forms. The present investigation was carried out to develop new simple, precise, rapid, and cost-effective stability indicating RP-HPLC method for the simultaneous estimation of aliskiren and amlodipine in pharmaceutical dosage form
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