Development and validation of an UV spectrophotometric method for the determination of aliskiren in tablets

Wrasse-Sangoi, Micheli; Secretti, Leonardo Trevisan; Diefenbach, Isabel Fração; Rolim, Clarice Madalena Bueno; Sangoi, Maximiliano da Silva

doi:10.1590/s0100-40422010000600021

Cited by 28 publications

(22 citation statements)

References 8 publications

(8 reference statements)

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“…A literature survey revealed several methods for the determination of ALS in pharmaceutical preparation or biological fluids alone or in combination with other antihypertensive agents. These methods include HPLC , CE , UV spectrophotometry and spectrofluorimetry . Several methods have also been reported for the estimation of AML alone or in combination with other antihypertensive agents such as HPLC , LC–MS , CE , UV spectrophotometry , and spectrofluorimetry .…”

Section: Introductionmentioning

confidence: 99%

Simultaneous determination of aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide in their triple mixture dosage form by capillary zone electrophoresis

et al. 2014

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A novel, specific, reliable, and accurate capillary zone electrophoretic method was developed and validated for the simultaneous determination of aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide in their triple mixture dosage form. Separation was carried out in a fused-silica capillary (57.0 cm total length and 50.0 cm effective length, 75.6 μm internal diameter) by applying a potential of 17 kV and a running buffer consisting of 40 mM phosphate buffer at pH 6.0 with UV detection at 245 nm. The method was suitably validated with respect to specificity, linearity, LOD, and LOQ, accuracy, precision, and robustness. The method showed good linearity in the ranges 1-10, 2.5-25, and 30-300 μg/mL with LODs of 0.11, 0.33, and 5.83 μg/mL for amlodipine besylate, hydrochlorothiazide, and aliskiren hemifumarate, respectively. The proposed method was successfully applied for the analysis of the studied drugs in their coformulated tablets. The results of the proposed method were statistically compared with those obtained by the RP-HPLC reference method revealing no significant differences in the performance of the methods regarding accuracy and precision.

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Section: Introductionmentioning

confidence: 99%

Simultaneous determination of aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide in their triple mixture dosage form by capillary zone electrophoresis

et al. 2014

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“…Validated analytical methods for the determination of ALI in pharmaceutical formulations were reported using spectrophotometric 13 and stability‐indicating LC methods 14. Analytical methods were reported for the determination of HCTZ in pharmaceutical formulations using spectrophotometry 15 and LC 16, 17.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous determination of aliskiren and hydrochlorothiazide from their pharmaceutical preparations using a validated stability‐indicating MEKC method

Sangoi

Wrasse-Sangoi

Oliveira

et al. 2011

J of Separation Science

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A stability-indicating MEKC method was developed and validated for the simultaneous determination of aliskiren (ALI) and hydrochlorothiazide (HCTZ) in pharmaceutical formulations using ranitidine as an internal standard (IS). Optimal conditions for the separation of ALI, HCTZ and its major impurity chlorothiazide (CTZ), IS and degradation products were investigated. The method employed 47 mM Tris buffer and 47 mM anionic detergent SDS solution at pH 10.2 as the background electrolyte. MEKC method was performed on a fused-silica capillary (40 cm) at 28°C. Applied voltage was 26 kV (positive polarity) and photodiode array (PDA) detector was set at 217 nm. The method was validated in accordance with the ICH requirements. The method was linear over the concentration range of 5-100 and 60-1200 μg/mL for HCTZ and ALI, respectively (r(2) >0.9997). The stability-indicating capability of the method was established by enforced degradation studies combined with peak purity assessment using the PDA detection. Precision and accuracy evaluated by RSD were lower than 2%. The method proved to be robust by a fractional factorial design evaluation. The proposed MEKC method was successfully applied for the quantitative analysis of ALI and HCTZ both individually and in a combined dosage tablet formulation to support the quality control.

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“…Literature survey revealed HPLC [1] , LC-MS [2] , spectroflurimetric and simultaneous UVspectrophotometric methods are reported for the estimation of aliskiren hemifumarate [3][4] , amlodipine [5][6][7][8][9][10] , hydrochlorothiazide [11][12][13][14][15] alone or in combination with other anti-hypertensive agents. So the present study aim to develop a simple, selective and precise RP-HPLC method was developed for the simultaneous estimation of Aliskiren hemifumarate, amlodipine besylate and hydrochlorothiazide in bulk drug and in combined dosage form.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of a Stability Indicating RP-HPLC Method for Simultaneous Estimation of Aliskiren Hemifumarate, Amlodipine Besylate and Hydrochlorothiazide in Bulk and Pharmaceutical Dosage Forms

Prathyusha¹,

Tengli²,

Chandan³

et al. 2014

IOSRJPBS

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Development and validation of an UV spectrophotometric method for the determination of aliskiren in tablets

Cited by 28 publications

References 8 publications

Simultaneous determination of aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide in their triple mixture dosage form by capillary zone electrophoresis

Simultaneous determination of aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide in their triple mixture dosage form by capillary zone electrophoresis

Simultaneous determination of aliskiren and hydrochlorothiazide from their pharmaceutical preparations using a validated stability‐indicating MEKC method

Development and Validation of a Stability Indicating RP-HPLC Method for Simultaneous Estimation of Aliskiren Hemifumarate, Amlodipine Besylate and Hydrochlorothiazide in Bulk and Pharmaceutical Dosage Forms

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