A Validated Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Aliskiren Hemifumarate and Amlodipine Besylate in Pharmaceutical Dosage Form

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 ) 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 g/mL for aliskiren and 2-15 g/mL for amlodipine, respectively. Limit of detection and limit of quantification for aliskiren are 0.161 g/mL and 0.489 g/mL and for amlodipine are 0.133 g/mL and 0.404 g/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.

Simultaneous Estimation of Aliskiren and Amlodipine in Combined Tablet Formulation by Simultaneous Equation and First Derivative Spectroscopic Methods

“…Several analytical methods have been reported for estimation of ALS and its combination with other drugs which includes spectrophotometry and HPLC [9][10][11][12][13]. Similarly, various spectrophotometric and HPLC methods have been reported for estimation of AML and its combination with other drugs [14][15][16][17][18]. In the present work, a successful attempt has been made to estimate both these drugs simultaneously using dual wavelength UV spectrophotometric method.…”

Stability Indicating RP-HPLC method development and validation for simultaneous quantification of antihistaminic & anti-asthmatic drug in bulk and tablet dosage form

“…These studies help to determine the inherent stability of the effective molecules in the drug product and the potential degradation products. 21,22 Preparing of sample stock solution For forced degradation studies, the powder sample was carefully weighed equivalent to 25 mg of LEV and 50 mg of MON and transferred to a 100 ml volumetric flask containing 70 ml of diluent, dissolving sonicate for 10 min.…”

“…Journal of Pharmaceutical and Biological Sciences, January-June, 2020;8(1):[12][13][14][15][16][17][18][19][20][21][22] …”

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“…1a) and Amlodipine is 3-ethyl-5-methyl 2-[(2-amino ethoxy)methyl]-4-(2-chlorophenyl)-1, 4 -dihydro pyridine-6-methyl-3,5-dicarboxylate (Fig. 1b) 11,12 . Analytical methods like HPLC, UVSpectrophotometric were reported for the characterization of individual drug and combination with other drug.…”