TITLE

RP-HPLC Method for Simultaneous Estimation of Aliskiren Hemi fumarate, Hydrochlorothiazide and Amlodipine in Pharmaceutical bulk drugs and Tablet dosage form

AUTHOR(S)
Alagar Raja, M.; Ragavendra, P.; Banji, David; Rao, K. N. V.; Chaithanya, Y.; Anusha, B.; Selvakumar, D.
PUB. DATE
August 2012
SOURCE
Journal of Pharmacy Research;2012, Vol. 5 Issue 8, p4580
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The analysis of aliskiren hemifumarate and hydrochlorothiazide and amlodipine by improved High Performance liquid chromatography method with UVdetector and data handling system is investigated. The improved HPLC-UV detector method for the separation and quantification of aliskiren hemifumarate and hydrochlorothiazide and amlodipine is described. Samples are analysed by means of reverse phase(RP) HPLC using a Waters C8 column (250×4.6mm,5μm particle size) ,and the mobile phase used as 20 mmol L-1 potassium dihydrogen phosphate buffer of pH adjusted to 6.5 ± 0.1 with sodium hydro×ide (NaOH) (A)and methanol(B) and acetonitrile(c). A: B: C ratio was 55:10:35 v/v for the initial 18.0 min and the flow rate is 1.2 ml/min. and the column temperature is set at ambient temperature and wavelength fi×ed at 220nm UV-detection. The retention times of aliskiren hemifumarate and hydrochlorothiazide and amlodipine are 3.24min, 12.01 min and 14.89 min respectively. The described method of aliskiren hemifumarate and hydrochlorothiazide and amlodipine is linear over a range of 150μg/mL to 750μg/mL for Aliskiren, 12.5μg/mL-62.5μg/mL for hydrochlorothiazide and 5μg/mL to 25μg/mL amlodipine. The method precision for the determination of assay was below 2.0%RSD. The percentage recoveries of active pharmaceutical ingredient (API) from dosage forms ranged from 99%-101%. The method is useful in the quality control of pharmaceutical formulations. This provides a complete separation and determination of aliskiren hemifumarate and hydrochlorothiazide and amlodipine. It is found that the method of RP-HPLC with UV-detection system for the analysis of aliskiren hemifumarate and hydrochlorothiazide and amlodipine is straight forward and applied in qualitative and quantitative analysis. And validation study compared as per ICH guideline.
ACCESSION #
84460118

 

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